Atlas FDA

KIS

45 FDA 510(k) clearances · Product code

19 daysmedian time to decision
49 days90th percentile
45clearances measured

FDA profile

Official device name
Sera, Animal And Human
Device class
Class I (low risk)
Regulation
21 CFR 864.2800
Medical specialty
Hematology
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RecordFirmDate
ANIMAL AND HUMAN SERA (K881287)Cell Culture Laboratories1988-04-05
BOVINE CALF SERUM SUPPLEMENTED #A-2159 (K880471)Hyclone Laboratories, Inc.1988-04-04
BOVINE CALF SERUM CATALOG #A-2119 (K880470)Hyclone Laboratories, Inc.1988-04-01
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (K872847)Candace Lane Corp.1987-08-10
MLC NORMAL SERUM (K870580)Rjo Biologicals, Inc.1987-04-08
FETAL BOVINE SERUM (K870938)Hyclone Laboratories, Inc.1987-03-31
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (K870467)Hyclone Laboratories, Inc.1987-03-24
CHARACTERIZED FETAL BOVINE SERUM #A-1115 (K870464)Hyclone Laboratories, Inc.1987-03-24
ADULT BOVINE SERUM (K870468)Hyclone Laboratories, Inc.1987-03-24
DEFINED FETAL BOVINE SERUM #A-1111 (K870463)Hyclone Laboratories, Inc.1987-03-24
DEFINED CALF BOVINE SERUM #A-2111 (K870466)Hyclone Laboratories, Inc.1987-03-24
6/40 FETAL BOVINE SERUM #A-1110 (K870465)Hyclone Laboratories, Inc.1987-03-24
DEFINED EQUINE SERUM #A-3311 (K870469)Hyclone Laboratories, Inc.1987-03-24
CHICKEN SERUM - STERILE FILTERED (K861810)Hazleton Research Products, Inc.1986-05-20
HUMAN AB SERUM - STERILE FILTERED (K861813)Hazleton Research Products, Inc.1986-05-20
HUMAN SERUM - STERILE FILTERED (K861812)Hazleton Research Products, Inc.1986-05-20
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE (K861815)Hazleton Research Products, Inc.1986-05-20
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE (K861816)Hazleton Research Products, Inc.1986-05-20
LAMB SERUM - STERILE FILTERED (K861809)Hazleton Research Products, Inc.1986-05-20
RHESUS MONKEY SERUM - STERILE FILTERED (K861814)Hazleton Research Products, Inc.1986-05-20
HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED (K861817)Hazleton Research Products, Inc.1986-05-20
MOUSE SERUM - STERILE FILTERED (K861811)Hazleton Research Products, Inc.1986-05-20
GAMMA-FREE HORSE SERUM (K860762)Flow Laboratories, Inc.1986-03-10
GOAT SERUM (29-391-54) (K860752)Flow Laboratories, Inc.1986-03-10
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB (K853803)Z.L. Bocknek Laboratories, Inc.1985-10-15
FETAL BOVINE SERUM, F4884 STERILE GROWT (K843629)Sigma Chemical Co.1984-10-01
CLEX (K833463)Dextran Products, Ltd.1983-11-21
NEWBORN CALF SERUM - STERILE (K812384)Dutchland Laboratories, Inc.1981-09-08
NATAL CALF (BOVINE) SERUM - STERILE (K812385)Dutchland Laboratories, Inc.1981-09-08
DONOR HORSE SERUM - STERILE (K812381)Dutchland Laboratories, Inc.1981-09-08
CALF (BOVINE) SERUM - STERILE (K812383)Dutchland Laboratories, Inc.1981-09-08
FETAL BOVINE SERUM - STERILE (K812386)Dutchland Laboratories, Inc.1981-09-08
RABBIT SERUM - STERILE (K812380)Dutchland Laboratories, Inc.1981-09-08
GUINEA PIG SERUM - STERILE (K812379)Dutchland Laboratories, Inc.1981-09-08
DONOR CALF (BOVINE-SERUM) - STERILE (K812382)Dutchland Laboratories, Inc.1981-09-08
ZETA-SERA D (K812329)Amf Biological and Diagnostics Co.1981-09-01
GOAT SERUM-STERILE (K810775)Dutchland Laboratories, Inc.1981-05-08
FETAL CALF SERUM (K810874)Tissue Culture Biologicals1981-04-23
NEWBORN BOVINE SERUM (K810903)Biolabs, Inc.1981-04-14
BOVINE CALF SERUM (K810904)Biolabs, Inc.1981-04-14
ANIMAL SERUM PRODUCTS (K810478)Animal Health Laboratories, Inc.1981-04-08
NORMLCERA (K810268)Medical Specialties Laboratories1981-03-06
FETAL BOVINE SERUM (K802418)S&S Biologicals1980-10-31
FETAL BOVINE SERUM (K800781)Biolabs, Inc.1980-04-21
GUINEA PIG WHOLE SERUM (K780009)Northeast Biomedical Labs., Inc.1978-01-20

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