Culture Media, Selective And Non-Differential

FDA product code JSJ · 307 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2360
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-03 – 1988-06-22

JSJ 1986-02-24

BIOTIS CETRIMIDE AGAR

Applicant Otisville Biotech, Inc.

K number K860394

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JSJ 1986-02-24

BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT

Applicant Otisville Biotech, Inc.

K number K860391

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JSJ 1986-02-24

BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN

Applicant Otisville Biotech, Inc.

K number K860390

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JSJ 1986-02-24

BIOTIS CLOSTRIDIUM DIFFICILE AGAR

Applicant Otisville Biotech, Inc.

K number K860383

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JSJ 1985-11-18

COLUMBIA CNA AGAR W/5% SHEEP BLOOD

Applicant R. Kent Richards, Inc.

K number K854457

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JSJ 1985-11-18

CAMPYLOBACTER BLOOD AGAR

Applicant R. Kent Richards, Inc.

K number K854456

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JSJ 1985-11-18

P.E.Z. AGAR (PHENYLETHANOL AGAR)

Applicant R. Kent Richards, Inc.

K number K854453

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JSJ 1985-08-19

BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN

Applicant Hardy Media

K number K853335

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JSJ 1985-08-19

APL SABOURAUD DEXTROSE AGAR

Applicant Apl Medical Supplies

K number K853231

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JSJ 1985-08-19

APL MYCOBIOTIC AGAR

Applicant Apl Medical Supplies

K number K853230

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JSJ 1985-08-19

APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)

Applicant Apl Medical Supplies

K number K853227

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JSJ 1985-08-19

CARIESCREEN - SM

Applicant Pharma-Medica of Scandinavia, Ltd.

K number K852987

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JSJ 1985-05-29

CHAMBER V-9 PLUS AGAR

Applicant Bug City Company, Inc.

K number K851238

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JSJ 1985-05-13

SELECTIVE STREPTOCOCCUS AGAR

Applicant Preferred Micro-Media

K number K851593

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JSJ 1985-05-13

SABOURAUD DEXTROSE AGAR

Applicant Preferred Micro-Media

K number K851592

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JSJ 1985-05-13

PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD

Applicant Preferred Micro-Media

K number K851591

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JSJ 1985-05-08

TRICHOMONAS BROTH (KUPFORBERG

Applicant Preferred Micro-Media

K number K851599

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JSJ 1985-05-02

GN BROTH

Applicant Preferred Micro-Media

K number K851582

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JSJ 1985-05-02

COLUMBIZ CNA AGAR W/5% SHEEP BLOOD

Applicant Preferred Micro-Media

K number K851580

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JSJ 1985-04-30

MYCOLOGY AGAR W/ANTIBOTICS

Applicant Preferred Micro-Media

K number K851590

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JSJ 1985-04-24

STREP-KIT

Applicant Culture Kits, Inc.

K number K850765

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JSJ 1985-04-22

SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC

Applicant Roche Diagnostic Systems, Inc.

K number K851249

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JSJ 1985-04-19

COBA AGAR

Applicant Micro Media Laboratories

K number K851348

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JSJ 1985-04-19

KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR

Applicant Micro Media Laboratories

K number K851347

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JSJ 1985-04-01

CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI

Applicant Hardy Media

K number K850555

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JSJ 1985-03-29

BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA

Applicant Granite Diagnostics, Inc.

K number K850970

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JSJ 1985-03-29

INHIBITORY MOLD AGAR PLATE

Applicant Granite Diagnostics, Inc.

K number K850969

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JSJ 1985-03-29

CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ

Applicant Oxoid U.S.A., Inc.

K number K850832

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JSJ 1985-03-22

SELENITE F BROTH

Applicant Rapid City Regional Hospital, Inc.

K number K850716

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JSJ 1985-03-20

SALT BROTH

Applicant Micro Media Laboratories

K number K850846

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JSJ 1985-03-11

CDC ANEROBIC BLOOD AGAR W/PEA, ANEROBIC PEA

Applicant Hardy Media

K number K850556

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JSJ 1985-03-11

LKV AGAR, LKV ANAEROBIC AGAR

Applicant Hardy Media

K number K850554

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JSJ 1985-03-07

SELECTIVE STREP AGAR

Applicant Hardy Media

K number K850557

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JSJ 1985-02-27

MALT AGAR

Applicant American Laboratory Supply, Inc.

K number K844932

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JSJ 1985-02-27

MYCOLOGICAL AGAR W/ANTIBIOTICS

Applicant American Laboratory Supply, Inc.

K number K844931

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JSJ 1985-02-27

INHIBITORY MOLD AGAR

Applicant American Laboratory Supply, Inc.

K number K844929

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JSJ 1985-01-07

CAMPYLOBACTER CVA AGAR

Applicant bioMerieux, Inc.

K number K844534

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JSJ 1985-01-07

TRICHOMONAS BROTH

Applicant bioMerieux, Inc.

K number K844533

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JSJ 1985-01-07

BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE

Applicant bioMerieux, Inc.

K number K844530

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JSJ 1985-01-07

SELENITE BROTH

Applicant bioMerieux, Inc.

K number K844527

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JSJ 1985-01-07

SELENITE CYSTINE BROTH

Applicant bioMerieux, Inc.

K number K844525

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JSJ 1985-01-07

GN BROTH

Applicant bioMerieux, Inc.

K number K844524

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JSJ 1985-01-07

CAMPYLOBACTER THIOGLYCOLLATE MEDIUM

Applicant bioMerieux, Inc.

K number K844523

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JSJ 1985-01-07

STREPTOCOCCUS SELECTIVE AGAR

Applicant bioMerieux, Inc.

K number K844518

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JSJ 1985-01-07

COLUMBIA CNA AGAR W/5% SHEEP BLOOD

Applicant bioMerieux, Inc.

K number K844517

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JSJ 1984-10-23

CAMPYLOCACTER SUPPLEMENT

Applicant Institute Virion , Ltd.

K number K843653

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JSJ 1984-10-23

SFP AGAR PLATES

Applicant Otisville Biotech, Inc.

K number K834424

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JSJ 1984-10-23

PHENYLETHYL ALCOHOL AGAR PLATE

Applicant Otisville Biotech, Inc.

K number K834422

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JSJ 1984-10-23

COLUMBIA CNA AGAR PLATE

Applicant Otisville Biotech, Inc.

K number K834419

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JSJ 1984-10-10

BIOTIS MYCOLOGICAL MEDIA & SLANT

Applicant Otisville Biotech, Inc.

K number K843766

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JSJ 1984-10-10

BIOTIS MYCOBIOTIC AGAR

Applicant Otisville Biotech, Inc.

K number K843765

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JSJ 1984-05-31

SELECTIVE CULTURE MED. COLUMBIA CNA

Applicant Microline Scientific

K number K841845

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JSJ 1984-05-31

SALMONELLA-SHIGELLA AGAR

Applicant The Montana Deaconess Medical Center

K number K841746

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JSJ 1984-05-25

SELECTIVE CULTURE MED. PHENYLETHYL ALCO

Applicant Microline Scientific

K number K841840

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JSJ 1984-05-25

SELECTIVE CULTURE MED. SELECTIVE STREP

Applicant Microline Scientific

K number K841839

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JSJ 1984-05-21

HAEMOPHILUS ISOLATION AGAR 2827

Applicant Gibco Laboratories Life Technologies, Inc.

K number K841673

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JSJ 1984-05-11

KF STREPTOCOCCUS AGAR

Applicant Oxoid U.S.A., Inc.

K number K841658

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JSJ 1984-05-11

CAMPYLOBACTER AGAR BASE

Applicant Oxoid U.S.A., Inc.

K number K840332

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JSJ 1984-05-07

COLUMBIA CNA AGAR

Applicant The Montana Deaconess Medical Center

K number K841754

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JSJ 1984-04-04

SELECTIVE & NON-DIFFERENTIAL

Applicant Smith River Biologicals

K number K841210

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JSJ 1984-03-26

PHENYLETHYL ALCOHOL BLOOD AGAR

Applicant Anaerobe Systems

K number K841140

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JSJ 1984-03-26

COLUMBIA AGAR W/COLISTIN, NALADIXIC

Applicant Anaerobe Systems

K number K841139

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JSJ 1984-03-26

SABOURAUD DEXTROSE AGAR W/CHLORAMPHE

Applicant Anaerobe Systems

K number K841136

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JSJ 1984-03-26

MYCOSEL AGAR W/CHLORAMPHENICOL &

Applicant Anaerobe Systems

K number K841135

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JSJ 1984-03-23

THAYER MARTIN MEDIUM

Applicant Anaerobe Systems

K number K841133

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JSJ 1984-03-23

BUFFERED CYE AGAR DEEP W/SUPPLEMENTS

Applicant Remel Co.

K number K840890

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JSJ 1984-02-27

BLOOD AGAR W/AMPICILLIN

Applicant Remel Co.

K number K840554

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JSJ 1984-02-27

MYCOLOGICAL SELECTIVE MEDIUM

Applicant Scientific Device Laboratory, Inc.

K number K840520

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JSJ 1984-02-27

DTM AGAR

Applicant Scientific Device Laboratory, Inc.

K number K840519

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JSJ 1984-02-13

GN BROTH TUBE

Applicant Otisville Biotech, Inc.

K number K840076

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JSJ 1984-02-13

KV BLOOD AGAR PLATE

Applicant Otisville Biotech, Inc.

K number K840074

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JSJ 1984-01-30

SABOURAUD DEXTROSE AGAR TUBE

Applicant Otisville Biotech, Inc.

K number K840078

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JSJ 1984-01-25

PUMP INFUSION WEARABLE INFUSION PUMP

Applicant Oximetrix, Inc.

K number K833966

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JSJ 1984-01-17

CAMPY BRUCELLA AGAR PLATE

Applicant Otisville Biotech, Inc.

K number K834417

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JSJ 1984-01-13

INHIBITORY MOLD AGAR

Applicant Hardy Media

K number K834325

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JSJ 1984-01-13

BRUCELLA W/H & K

Applicant Hardy Media

K number K834318

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JSJ 1984-01-13

SELENITE BROTH

Applicant Hardy Media

K number K834317

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JSJ 1984-01-13

CAMPY 5

Applicant Hardy Media

K number K834314

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JSJ 1984-01-13

CAMPY 3

Applicant Hardy Media

K number K834313

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JSJ 1984-01-13

PEPTIC DIGEST AGAR

Applicant Micro Media Laboratories

K number K834020

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JSJ 1984-01-12

CAMPY 5H

Applicant Hardy Media

K number K834326

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JSJ 1984-01-11

CVA

Applicant Remel Co.

K number K833967

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JSJ 1984-01-03

CEB

Applicant Remel Co.

K number K834068

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JSJ 1984-01-03

DERMATOPHYTE TEST MEDIUM

Applicant Micro Media Laboratories

K number K834010

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JSJ 1984-01-03

SELECTIVE STREPTOCOCCUS AGAR

Applicant Micro Media Laboratories

K number K834005

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JSJ 1983-12-30

SABOURAUD DEXTROSE AGAR

Applicant Micro Media Laboratories

K number K834008

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JSJ 1983-12-22

CAMPY MEDIUM

Applicant Micro Media Laboratories

K number K834018

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JSJ 1983-12-22

CHOCOLATE AGAR W/CHEMICALLY DEFINED

Applicant Micro Media Laboratories

K number K834017

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JSJ 1983-12-16

CLOSTRIDIUM DIFFICILE EY AGAR P2787

Applicant Gibco Laboratories Life Technologies, Inc.

K number K833760

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JSJ 1983-12-12

BRUCELLA BROTH

Applicant Oxoid U.S.A., Inc.

K number K833887

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JSJ 1983-12-12

BRUCELLA AGAR

Applicant Oxoid U.S.A., Inc.

K number K833886

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JSJ 1983-10-27

LOWENSTEIN-JENSEN MEDIUM BASE

Applicant Acumedia Manufacturers, Inc.

K number K833220

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JSJ 1983-10-27

CLOSTRIDIUM DIFFICILE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K833136

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JSJ 1983-10-27

CIN AGAR YERSINIA-SELECTIVE AGAR

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K833010

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JSJ 1983-10-04

BRILLIANT GREEN AGAR PLATE

Applicant Otisville Biotech, Inc.

K number K832536

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JSJ 1983-09-26

SABOURAUD DEXTROSE AGAR

Applicant Troy Biologicals, Inc.

K number K832861

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JSJ 1983-09-26

SXT BLOOD AGAR

Applicant Troy Biologicals, Inc.

K number K832860

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JSJ 1983-09-12

SF BROTH

Applicant Carroll Biological Corp.

K number K832615

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JSJ 1983-09-12

SELENITE BROTH

Applicant Carroll Biological Corp.

K number K832614

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JSJ 1983-09-12

MANNITOL SALT AGAR

Applicant Carroll Biological Corp.

K number K832613

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