Media And Components, Synthetic Cell And Tissue Culture

FDA product code KIT · 367 cleared devices

Class 1 Hematology

Regulation: 21 CFR 864.2220
Review panel: PA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-07-21 – 1989-05-22

KIT 1983-10-28

MEM-EAGLE W/EARLES SALTS W/IVEAA

Applicant Sigma Chemical Co.

K number K833163

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KIT 1983-10-27

L-15-LEIBOVITZ W/L-GLUTAMINE-L4386

Applicant Sigma Chemical Co.

K number K833164

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KIT 1983-10-14

TISSUE TRANSPORT MEDIUM

Applicant Northern Scientific, Inc.

K number K833016

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KIT 1983-09-29

SPINNER SALT SOLUTION S-6011 W/EARLES

Applicant Sigma Chemical Co.

K number K832930

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KIT 1983-09-29

DULBECCOS MODIFIED EAGLES MEDIUM D5648

Applicant Sigma Chemical Co.

K number K832842

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KIT 1983-09-29

NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM

Applicant Sigma Chemical Co.

K number K832841

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KIT 1983-09-29

BASAL MED. #B9763 W/HANKS SALTS W/L-G

Applicant Sigma Chemical Co.

K number K832836

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KIT 1983-09-29

DULBECCOS PHOSPHATE BUFFERED SALINE

Applicant Sigma Chemical Co.

K number K832835

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KIT 1983-09-26

MINIMUM ESSENTIAL MED. EAGLE M4642 W/

Applicant Sigma Chemical Co.

K number K832840

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KIT 1983-09-26

HANKS BALANCED SALT MIXTURE H6136

Applicant Sigma Chemical Co.

K number K832839

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KIT 1983-09-26

EARLES BALANCED SALT MIXTURE #E6132

Applicant Sigma Chemical Co.

K number K832838

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KIT 1983-09-26

NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA

Applicant Sigma Chemical Co.

K number K832837

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KIT 1983-09-12

MINIMUM ESSENTIAL MED. EAGLE M0268

Applicant Sigma Chemical Co.

K number K832690

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KIT 1983-09-12

MCCOY'S 5A #M4892 W/L-GLUTAMINE AND

Applicant Sigma Chemical Co.

K number K832689

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KIT 1983-09-12

DULBECCO'S MODIFIED EAGLE #D5523-

Applicant Sigma Chemical Co.

K number K832688

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KIT 1983-09-12

BASAL MED. EAGLE #B9888 W/L-GLUTAMINE

Applicant Sigma Chemical Co.

K number K832687

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KIT 1983-07-07

CHLAMYDIA OVERBY MEDIA

Applicant Viromed Laboratories, Inc.

K number K831686

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KIT 1983-07-06

BASAL MEDIUM EAGLE W/EARLES SALTS, &

Applicant Sigma Chemical Co.

K number K831745

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KIT 1983-07-06

SF REFEEDING MEDIA

Applicant Viromed Laboratories, Inc.

K number K831685

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KIT 1983-06-22

RPMI-1640 MEDIUM W/L-GLUTAMINE &

Applicant Sigma Chemical Co.

K number K831519

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KIT 1982-07-27

POWDERED RPMI-1634 MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821919

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KIT 1982-07-27

POWDERED RPMI-1603 MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821918

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KIT 1982-07-27

WAYMOUTH'S POWDER MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821917

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KIT 1982-07-27

IMPROVED MEM-RICHTER'S POWDER MODIF.

Applicant Dutchland Laboratories, Inc.

K number K821916

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KIT 1982-07-27

BME AUTOCLAVABLE MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821915

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KIT 1982-07-27

COON'S F-12 POWDER MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821914

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KIT 1982-07-27

ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K821913

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KIT 1982-07-27

MCCOY'S POWDER MEDIUM 5A SUSPENSION

Applicant Dutchland Laboratories, Inc.

K number K821912

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KIT 1982-07-27

S-MEM-JOKLIK'S POWDER

Applicant Dutchland Laboratories, Inc.

K number K821911

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KIT 1982-04-21

HANK'S 199 POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820931

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KIT 1982-04-21

FISCHER'S POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820930

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KIT 1982-04-21

RPMI-164POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820929

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KIT 1982-04-21

E-BME POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820926

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KIT 1982-04-21

H - BME POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820925

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KIT 1982-04-21

HAMS F-12 POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820924

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KIT 1982-04-21

HAMS F-10 POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820922

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KIT 1982-04-21

D-MEM-LOW GLUCOSE-POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820921

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KIT 1982-04-21

MCCOY'S 5A POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820920

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KIT 1982-04-21

EARLE'S-199 POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820919

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KIT 1982-04-21

HMEM POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820918

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KIT 1982-04-21

L-15 POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820917

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KIT 1982-04-21

D-MEM-HIGH GLUCOSE-POWDERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820916

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KIT 1982-04-21

MEM AUTOCLAVABLE MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820915

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KIT 1982-04-21

EMEM POWERED MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K820914

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KIT 1982-04-08

MEM VITAMINS (100X

Applicant Dutchland Laboratories, Inc.

K number K820509

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KIT 1982-03-26

MEM NON-ESSENTIAL AMINO ACIDS (100X)

Applicant Dutchland Laboratories, Inc.

K number K820508

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KIT 1982-03-26

SODIUM PYRUVATE (100MM)

Applicant Dutchland Laboratories, Inc.

K number K820495

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KIT 1981-11-24

DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM

Applicant Dutchland Laboratories, Inc.

K number K812885

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KIT 1981-11-10

CHANG MEDIUM

Applicant Hana Biologics, Inc.

K number K812820

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KIT 1981-10-23

CELL CULTURE REAGENTS

Applicant M.A. Bioproducts

K number K812531

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KIT 1981-10-02

VITROGEN TM 100

Applicant Collagen Corp.

K number K812617

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KIT 1981-05-13

ALSEVER'S SOLUTION (MODIFIED)

Applicant Dutchland Laboratories, Inc.

K number K810783

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KIT 1981-05-13

L-GLUTAMINE

Applicant Dutchland Laboratories, Inc.

K number K810781

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KIT 1981-05-13

SODIUM BICARBONATE (7.5%) SOLUTION

Applicant Dutchland Laboratories, Inc.

K number K810780

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KIT 1981-05-13

BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT

Applicant Dutchland Laboratories, Inc.

K number K810778

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KIT 1981-05-13

PENICILLIN-STREPTOMYCIN MIXTURE

Applicant Dutchland Laboratories, Inc.

K number K810776

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KIT 1981-05-13

WATER-TISSUE CULTURE GRADE

Applicant Dutchland Laboratories, Inc.

K number K810774

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KIT 1981-05-13

BASAL MEDIUM EAGLE W/HANKS' SALTS

Applicant Dutchland Laboratories, Inc.

K number K810773

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KIT 1981-05-13

MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE

Applicant Dutchland Laboratories, Inc.

K number K810772

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KIT 1981-05-13

L-15 MEDIUM (MODIFIED)

Applicant Dutchland Laboratories, Inc.

K number K810771

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KIT 1981-05-13

MED. 199(MODIFIED) W/HANKS' SALTS

Applicant Dutchland Laboratories, Inc.

K number K810770

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KIT 1981-05-13

MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE

Applicant Dutchland Laboratories, Inc.

K number K810769

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KIT 1981-05-13

MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS

Applicant Dutchland Laboratories, Inc.

K number K810768

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KIT 1981-05-08

RPMI 1640 MEDIUM

Applicant Dutchland Laboratories, Inc.

K number K810767

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KIT 1981-03-23

FUNGIZONE

Applicant Dutchland Laboratories, Inc.

K number K810784

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KIT 1980-12-30

SERUM FREE TISSUE CULTURE MEDIA

Applicant Cartaya Assoc.

K number K803041

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KIT 1977-07-21

TISSUE CULTURE MEDIA W/HEPES BUFFER

Applicant Microbiological Assoc.

K number K770764

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