Culture Media, Multiple Biochemical Test

FDA product code JSE · 53 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2320
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-02-18 – 1996-07-25

JSE 1996-07-25

MLX MICROTITER PLATE LUMINOMETER

Applicant Dynatech Laboratories, Inc.

K number K962265

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JSE 1988-10-12

X-ACT LDC/IND

Applicant Pro-Lab, Inc.

K number K883996

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JSE 1988-10-12

X-ACT UREA/TDA

Applicant Pro-Lab, Inc.

K number K883995

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JSE 1988-03-31

MIL MEDIUM

Applicant Hardy Media

K number K880133

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JSE 1988-03-31

MRVP BROTH

Applicant Hardy Media

K number K880116

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JSE 1987-11-20

KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR

Applicant Lakewood Biochemical Co., Inc.

K number K874537

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JSE 1987-04-03

CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES

Applicant bioMerieux, Inc.

K number K871096

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JSE 1987-01-05

MICRODILUTION IDENTIFICATION PANELS

Applicant American Micro Scan

K number K864674

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JSE 1986-07-03

BIOTIS LITMUS MILK

Applicant Otisville Biotech, Inc.

K number K862393

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JSE 1986-02-24

BIOTIS SIMMON CITRATE AGAR

Applicant Otisville Biotech, Inc.

K number K860415

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JSE 1986-02-24

BIOTIS ORNITHINE INDOLE MOTILITY MEDIA

Applicant Otisville Biotech, Inc.

K number K860414

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JSE 1986-02-24

BIOTIS TSI

Applicant Otisville Biotech, Inc.

K number K860413

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JSE 1986-02-24

BIOTIS SIM MEDIUM

Applicant Otisville Biotech, Inc.

K number K860412

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JSE 1986-02-20

AUSTIN ENTERIC SYSTEM

Applicant Austin Biological Laboratories

K number K860194

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JSE 1985-03-29

CTAPI - NEISSERA SCREEN

Applicant Analytical Products, Inc.

K number K850982

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JSE 1985-03-20

DIFFERENTIAL CULTURE MEDIUM

Applicant Roseville Medical Laboratoriesu

K number K850734

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JSE 1985-03-11

SIM MEDIUM

Applicant Hardy Media

K number K850551

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JSE 1985-03-11

LYSINE IRON AGAR LIA

Applicant Hardy Media

K number K850548

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JSE 1985-03-11

MOTILITY INDOLE ORNITHINE AGAR

Applicant Hardy Media

K number K850547

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JSE 1985-03-11

KLIGLER IRON AGAR KIA

Applicant Hardy Media

K number K850546

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JSE 1984-10-10

BIOTIS KLIGLER IRON AGAR

Applicant Otisville Biotech, Inc.

K number K843768

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JSE 1984-07-02

RIM STREP KIT

Applicant Austin Biological Laboratories

K number K842451

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JSE 1984-07-02

BIOTIS LD-PRESUMPTO QUADRANT PLATE

Applicant Otisville Biotech, Inc.

K number K842424

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JSE 1984-04-17

MULTIPLE BIOCHEMICAL TEST

Applicant Smith River Biologicals

K number K841204

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JSE 1983-12-22

SIM MEDIUM

Applicant Micro Media Laboratories

K number K834012

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JSE 1983-12-22

MYCOBIOTIC AGAR

Applicant Micro Media Laboratories

K number K834004

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JSE 1983-12-22

MOTILITY INDOLE ORNITHINE-MEDIUM

Applicant Micro Media Laboratories

K number K834003

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JSE 1983-12-22

LYSINE IRON AGAR

Applicant Micro Media Laboratories

K number K834002

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JSE 1983-12-22

KLIGLER IRON AGAR

Applicant Micro Media Laboratories

K number K834001

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JSE 1983-09-12

INDOLE NITRATE MEDIUM

Applicant Acumedia Manufacturers, Inc.

K number K832568

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JSE 1983-05-18

API 20GP

Applicant Analytical Products, Inc.

K number K830525

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JSE 1982-11-16

CHRISTENSENS CITRATE SULFIDE AGAR

Applicant Granite Diagnostics, Inc.

K number K822998

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JSE 1982-11-05

LECITHIN LACTOSE AGAR

Applicant Granite Diagnostics, Inc.

K number K823072

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JSE 1982-07-08

TRIPLE SUGAR IRON AGAR SLANT

Applicant Hardy Media

K number K821592

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JSE 1982-04-16

CULTURE MEDIA, NON-SELECTIVE/DIFFER

Applicant Blue Ridge Media Co.

K number K820842

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JSE 1982-04-16