510(k) K810478
- Device
- ANIMAL SERUM PRODUCTS
- Applicant
- ANIMAL HEALTH LABORATORIES, INC.
- 510(k) number
- K810478
- Product code
- KIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-08
- Date received
- 1981-02-23
- Regulation
- 864.2800
- Classification name
- Sera, Animal And Human
- Medical specialty
- Hematology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017716384
- 3006236690
- 3039436068
- 9710594
- 9710646
- 1932313
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881287 | ANIMAL AND HUMAN SERA | Cell Culture Laboratories | 1988-04-05 |
| K880471 | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | Hyclone Laboratories, Inc. | 1988-04-04 |
| K880470 | BOVINE CALF SERUM CATALOG #A-2119 | Hyclone Laboratories, Inc. | 1988-04-01 |
| K872847 | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | Candace Lane Corp. | 1987-08-10 |
| K870580 | MLC NORMAL SERUM | Rjo Biologicals, Inc. | 1987-04-08 |
| K870938 | FETAL BOVINE SERUM | Hyclone Laboratories, Inc. | 1987-03-31 |
| K870465 | 6/40 FETAL BOVINE SERUM #A-1110 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870463 | DEFINED FETAL BOVINE SERUM #A-1111 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870464 | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870466 | DEFINED CALF BOVINE SERUM #A-2111 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870467 | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870468 | ADULT BOVINE SERUM | Hyclone Laboratories, Inc. | 1987-03-24 |
| K870469 | DEFINED EQUINE SERUM #A-3311 | Hyclone Laboratories, Inc. | 1987-03-24 |
| K861817 | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | Hazleton Research Products, Inc. | 1986-05-20 |
| K861816 | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | Hazleton Research Products, Inc. | 1986-05-20 |
Legacy Summary#
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FDA Review#
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