FDA Product Code
FDA Product Code KIS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.2800
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K881287 | ANIMAL AND HUMAN SERA | Cell Culture Laboratories | 1988-04-05 | Traditional | PDF ↗ |
| K880471 | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | Hyclone Laboratories, Inc. | 1988-04-04 | Traditional | PDF ↗ |
| K880470 | BOVINE CALF SERUM CATALOG #A-2119 | Hyclone Laboratories, Inc. | 1988-04-01 | Traditional | PDF ↗ |
| K872847 | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | Candace Lane Corp. | 1987-08-10 | Traditional | PDF ↗ |
| K870580 | MLC NORMAL SERUM | Rjo Biologicals, Inc. | 1987-04-08 | Traditional | PDF ↗ |
| K870938 | FETAL BOVINE SERUM | Hyclone Laboratories, Inc. | 1987-03-31 | Traditional | PDF ↗ |
| K870467 | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870466 | DEFINED CALF BOVINE SERUM #A-2111 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870468 | ADULT BOVINE SERUM | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870463 | DEFINED FETAL BOVINE SERUM #A-1111 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870464 | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870469 | DEFINED EQUINE SERUM #A-3311 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870465 | 6/40 FETAL BOVINE SERUM #A-1110 | Hyclone Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K861813 | HUMAN AB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861816 | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861811 | MOUSE SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861812 | HUMAN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861815 | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861810 | CHICKEN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861814 | RHESUS MONKEY SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861817 | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861809 | LAMB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K860752 | GOAT SERUM (29-391-54) | Flow Laboratories, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K860762 | GAMMA-FREE HORSE SERUM | Flow Laboratories, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K853803 | FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB | Z.L. Bocknek Laboratories, Inc. | 1985-10-15 | Traditional | PDF ↗ |
| K843629 | FETAL BOVINE SERUM, F4884 STERILE GROWT | Sigma Chemical Co. | 1984-10-01 | Traditional | PDF ↗ |
| K833463 | CLEX | Dextran Products, Ltd. | 1983-11-21 | Traditional | PDF ↗ |
| K812382 | DONOR CALF (BOVINE-SERUM) - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812384 | NEWBORN CALF SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812385 | NATAL CALF (BOVINE) SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812380 | RABBIT SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812386 | FETAL BOVINE SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812383 | CALF (BOVINE) SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812381 | DONOR HORSE SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812379 | GUINEA PIG SERUM - STERILE | Dutchland Laboratories, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K812329 | ZETA-SERA D | Amf Biological and Diagnostics Co. | 1981-09-01 | Traditional | PDF ↗ |
| K810775 | GOAT SERUM-STERILE | Dutchland Laboratories, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K810874 | FETAL CALF SERUM | Tissue Culture Biologicals | 1981-04-23 | Traditional | PDF ↗ |
| K810903 | NEWBORN BOVINE SERUM | Biolabs, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810904 | BOVINE CALF SERUM | Biolabs, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810478 | ANIMAL SERUM PRODUCTS | Animal Health Laboratories, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K810268 | NORMLCERA | Medical Specialties Laboratories | 1981-03-06 | Traditional | PDF ↗ |
| K802418 | FETAL BOVINE SERUM | S&S Biologicals | 1980-10-31 | Traditional | PDF ↗ |
| K800781 | FETAL BOVINE SERUM | Biolabs, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K780009 | GUINEA PIG WHOLE SERUM | Northeast Biomedical Labs., Inc. | 1978-01-20 | Traditional | PDF ↗ |
Product code KIS · Class I · Hematology. Data: openFDA.