Defined Calf Bovine Serum #A-2111
FDA 510(k) K870466 · Hyclone Laboratories, Inc.
510(k) numberK870466
Submission
- Device name
- Defined Calf Bovine Serum #A-2111
- Applicant
- Hyclone Laboratories, Inc.
Logan, UT, US - Received
- February 3, 1987
- Decision date
- March 24, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIS – Sera, Animal And Human
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2800
- Specialty
- Hematology
Other 510(k)s with product code KIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881287 | Animal and Human SeraKIS · Traditional | Cell Culture Laboratories | 04/05/1988SE |
| K880471 | Bovine Calf Serum Supplemented #A-2159KIS · Traditional | Hyclone Laboratories, Inc. | 04/04/1988SE |
| K880470 | Bovine Calf Serum Catalog #A-2119KIS · Traditional | Hyclone Laboratories, Inc. | 04/01/1988SE |
| K872847 | Solcoseryl Tissue Culture Growth SupplementKIS · Traditional | Candace Lane Corp. | 08/10/1987SE |
| K870580 | MLC Normal SerumKIS · Traditional | Rjo Biologicals, Inc. | 04/08/1987SE |
| K870938 | Fetal Bovine SerumKIS · Traditional | Hyclone Laboratories, Inc. | 03/31/1987SE |
| K870469 | Defined Equine Serum #A-3311KIS · Traditional | Hyclone Laboratories, Inc. | 03/24/1987SE |
| K870468 | Adult Bovine SerumKIS · Traditional | Hyclone Laboratories, Inc. | 03/24/1987SE |
| K870467 | Defined Calf Bovine Serum Supplemented #A-2151KIS · Traditional | Hyclone Laboratories, Inc. | 03/24/1987SE |
| K870465 | 6/40 Fetal Bovine Serum #A-1110KIS · Traditional | Hyclone Laboratories, Inc. | 03/24/1987SE |
More from Hyclone Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884654 | Alphacalf SerumKIT · Traditional | 11/30/1988SE |
| K880471 | Bovine Calf Serum Supplemented #A-2159KIS · Traditional | 04/04/1988SE |
| K880470 | Bovine Calf Serum Catalog #A-2119KIS · Traditional | 04/01/1988SE |
| K870938 | Fetal Bovine SerumKIS · Traditional | 03/31/1987SE |
| K870469 | Defined Equine Serum #A-3311KIS · Traditional | 03/24/1987SE |
| K870468 | Adult Bovine SerumKIS · Traditional | 03/24/1987SE |
| K870467 | Defined Calf Bovine Serum Supplemented #A-2151KIS · Traditional | 03/24/1987SE |
| K870465 | 6/40 Fetal Bovine Serum #A-1110KIS · Traditional | 03/24/1987SE |
| K870464 | Characterized Fetal Bovine Serum #A-1115KIS · Traditional | 03/24/1987SE |
| K870463 | Defined Fetal Bovine Serum #A-1111KIS · Traditional | 03/24/1987SE |
Questions and answers
When was Defined Calf Bovine Serum #A-2111 cleared by the FDA?
Defined Calf Bovine Serum #A-2111 (K870466) received a 510(k) decision of Substantially Equivalent on March 24, 1987, 49 days after the submission was received.
What is the product code of K870466?
The FDA product code is KIS – Sera, Animal And Human, a Class I (low risk) device regulated under 21 CFR 864.2800.