KIS · Sera, Animal And Human
Hematology · 21 CFR 864.2800 · Class 1
Overview
| Product Code | KIS |
|---|---|
| Device Name | Sera, Animal And Human |
| Regulation | 21 CFR 864.2800 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881287 | ANIMAL AND HUMAN SERA | Cell Culture Laboratories | Apr 5, 1988 | SESE |
| K880471 | BOVINE CALF SERUM SUPPLEMENTED #A-2159 | Hyclone Laboratories, Inc. | Apr 4, 1988 | SESE |
| K880470 | BOVINE CALF SERUM CATALOG #A-2119 | Hyclone Laboratories, Inc. | Apr 1, 1988 | SESE |
| K872847 | SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT | Candace Lane Corp. | Aug 10, 1987 | SESE |
| K870580 | MLC NORMAL SERUM | Rjo Biologicals, Inc. | Apr 8, 1987 | SESE |
| K870938 | FETAL BOVINE SERUM | Hyclone Laboratories, Inc. | Mar 31, 1987 | SESE |
| K870469 | DEFINED EQUINE SERUM #A-3311 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870468 | ADULT BOVINE SERUM | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870467 | DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870466 | DEFINED CALF BOVINE SERUM #A-2111 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870465 | 6/40 FETAL BOVINE SERUM #A-1110 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870464 | CHARACTERIZED FETAL BOVINE SERUM #A-1115 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K870463 | DEFINED FETAL BOVINE SERUM #A-1111 | Hyclone Laboratories, Inc. | Mar 24, 1987 | SESE |
| K861817 | HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861816 | MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861815 | BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861814 | RHESUS MONKEY SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861813 | HUMAN AB SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861812 | HUMAN SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
| K861811 | MOUSE SERUM - STERILE FILTERED | Hazleton Research Products, Inc. | May 20, 1986 | SESE |
Top Applicants
- Hyclone Laboratories, Inc. — 10 clearances
- Dutchland Laboratories, Inc. — 9 clearances
- Hazleton Research Products, Inc. — 9 clearances
- Biolabs, Inc. — 3 clearances
- Flow Laboratories, Inc. — 2 clearances
