KIS — Sera, Animal And Human Class I
FDA product code KIS covers "Sera, Animal And Human", a Class I medical device regulated under 21 CFR 864.2800. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KIS
- Device Class
- Class I
- Regulation Number
- 864.2800
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K881287 | cell culture laboratories | ANIMAL AND HUMAN SERA | April 5, 1988 |
| K880471 | hyclone laboratories | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | April 4, 1988 |
| K880470 | hyclone laboratories | BOVINE CALF SERUM CATALOG #A-2119 | April 1, 1988 |
| K872847 | candace lane | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | August 10, 1987 |
| K870580 | rjo biologicals | MLC NORMAL SERUM | April 8, 1987 |
| K870938 | hyclone laboratories | FETAL BOVINE SERUM | March 31, 1987 |
| K870469 | hyclone laboratories | DEFINED EQUINE SERUM #A-3311 | March 24, 1987 |
| K870464 | hyclone laboratories | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | March 24, 1987 |
| K870467 | hyclone laboratories | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | March 24, 1987 |
| K870463 | hyclone laboratories | DEFINED FETAL BOVINE SERUM #A-1111 | March 24, 1987 |
| K870466 | hyclone laboratories | DEFINED CALF BOVINE SERUM #A-2111 | March 24, 1987 |
| K870468 | hyclone laboratories | ADULT BOVINE SERUM | March 24, 1987 |
| K870465 | hyclone laboratories | 6/40 FETAL BOVINE SERUM #A-1110 | March 24, 1987 |
| K861815 | hazleton research products | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE | May 20, 1986 |
| K861813 | hazleton research products | HUMAN AB SERUM - STERILE FILTERED | May 20, 1986 |
| K861811 | hazleton research products | MOUSE SERUM - STERILE FILTERED | May 20, 1986 |
| K861812 | hazleton research products | HUMAN SERUM - STERILE FILTERED | May 20, 1986 |
| K861817 | hazleton research products | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | May 20, 1986 |
| K861814 | hazleton research products | RHESUS MONKEY SERUM - STERILE FILTERED | May 20, 1986 |
| K861816 | hazleton research products | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | May 20, 1986 |