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Sera, Animal And Human

FDA product code KIS · 45 cleared devices

Class 1 Hematology

Regulation: 21 CFR 864.2800
Review panel: PA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-01-20 – 1988-04-05

KIS 1988-04-05

ANIMAL AND HUMAN SERA

Applicant Cell Culture Laboratories

K number K881287

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KIS 1988-04-04

BOVINE CALF SERUM SUPPLEMENTED #A-2159

Applicant Hyclone Laboratories, Inc.

K number K880471

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KIS 1988-04-01

BOVINE CALF SERUM CATALOG #A-2119

Applicant Hyclone Laboratories, Inc.

K number K880470

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KIS 1987-08-10

SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT

Applicant Candace Lane Corp.

K number K872847

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KIS 1987-04-08

MLC NORMAL SERUM

Applicant Rjo Biologicals, Inc.

K number K870580

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KIS 1987-03-31

FETAL BOVINE SERUM

Applicant Hyclone Laboratories, Inc.

K number K870938

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KIS 1987-03-24

DEFINED EQUINE SERUM #A-3311

Applicant Hyclone Laboratories, Inc.

K number K870469

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KIS 1987-03-24

ADULT BOVINE SERUM

Applicant Hyclone Laboratories, Inc.

K number K870468

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KIS 1987-03-24

DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151

Applicant Hyclone Laboratories, Inc.

K number K870467

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KIS 1987-03-24

DEFINED CALF BOVINE SERUM #A-2111

Applicant Hyclone Laboratories, Inc.

K number K870466

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KIS 1987-03-24

6/40 FETAL BOVINE SERUM #A-1110

Applicant Hyclone Laboratories, Inc.

K number K870465

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KIS 1987-03-24

CHARACTERIZED FETAL BOVINE SERUM #A-1115

Applicant Hyclone Laboratories, Inc.

K number K870464

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KIS 1987-03-24

DEFINED FETAL BOVINE SERUM #A-1111

Applicant Hyclone Laboratories, Inc.

K number K870463

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KIS 1986-05-20

HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED

Applicant Hazleton Research Products, Inc.

K number K861817

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KIS 1986-05-20

MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE

Applicant Hazleton Research Products, Inc.

K number K861816

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KIS 1986-05-20

BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE

Applicant Hazleton Research Products, Inc.

K number K861815

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KIS 1986-05-20

RHESUS MONKEY SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861814

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KIS 1986-05-20

HUMAN AB SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861813

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KIS 1986-05-20

HUMAN SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861812

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KIS 1986-05-20

MOUSE SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861811

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KIS 1986-05-20

CHICKEN SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861810

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KIS 1986-05-20

LAMB SERUM - STERILE FILTERED

Applicant Hazleton Research Products, Inc.

K number K861809

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KIS 1986-03-10

GAMMA-FREE HORSE SERUM

Applicant Flow Laboratories, Inc.

K number K860762

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KIS 1986-03-10

GOAT SERUM (29-391-54)

Applicant Flow Laboratories, Inc.

K number K860752

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KIS 1985-10-15

FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB

Applicant Z.L. Bocknek Laboratories, Inc.

K number K853803

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KIS 1984-10-01

FETAL BOVINE SERUM, F4884 STERILE GROWT

Applicant Sigma Chemical Co.

K number K843629

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KIS 1983-11-21

CLEX

Applicant Dextran Products, Ltd.

K number K833463

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KIS 1981-09-08

FETAL BOVINE SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812386

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KIS 1981-09-08

NATAL CALF (BOVINE) SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812385

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KIS 1981-09-08

NEWBORN CALF SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812384

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KIS 1981-09-08

CALF (BOVINE) SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812383

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KIS 1981-09-08

DONOR CALF (BOVINE-SERUM) - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812382

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KIS 1981-09-08

DONOR HORSE SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812381

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KIS 1981-09-08

RABBIT SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812380

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KIS 1981-09-08

GUINEA PIG SERUM - STERILE

Applicant Dutchland Laboratories, Inc.

K number K812379

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KIS 1981-09-01

ZETA-SERA D

Applicant Amf Biological and Diagnostics Co.

K number K812329

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KIS 1981-05-08

GOAT SERUM-STERILE

Applicant Dutchland Laboratories, Inc.

K number K810775

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KIS 1981-04-23

FETAL CALF SERUM

Applicant Tissue Culture Biologicals

K number K810874

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KIS 1981-04-14

BOVINE CALF SERUM

Applicant Biolabs, Inc.

K number K810904

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KIS 1981-04-14

NEWBORN BOVINE SERUM

Applicant Biolabs, Inc.

K number K810903

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KIS 1981-04-08

ANIMAL SERUM PRODUCTS

Applicant Animal Health Laboratories, Inc.

K number K810478

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KIS 1981-03-06

NORMLCERA

Applicant Medical Specialties Laboratories

K number K810268

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KIS 1980-10-31

FETAL BOVINE SERUM

Applicant S&S Biologicals

K number K802418

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KIS 1980-04-21

FETAL BOVINE SERUM

Applicant Biolabs, Inc.

K number K800781

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KIS 1978-01-20

GUINEA PIG WHOLE SERUM

Applicant Northeast Biomedical Labs., Inc.

K number K780009

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