Gamma-Free Horse Serum
FDA 510(k) K860762 · Flow Laboratories, Inc.
510(k) numberK860762
Submission
- Device name
- Gamma-Free Horse Serum
- Applicant
- Flow Laboratories, Inc.
Mclean, VA, US - Received
- February 28, 1986
- Decision date
- March 10, 1986
- 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 |
| K870466 | Defined Calf Bovine Serum #A-2111KIS · Traditional | Hyclone Laboratories, Inc. | 03/24/1987SE |
More from Hyclone Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
| K844418 | Titertek Multiskan MCCJJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Gamma-Free Horse Serum cleared by the FDA?
Gamma-Free Horse Serum (K860762) received a 510(k) decision of Substantially Equivalent on March 10, 1986, 10 days after the submission was received.
What is the product code of K860762?
The FDA product code is KIS – Sera, Animal And Human, a Class I (low risk) device regulated under 21 CFR 864.2800.