Zeta-Sera D
FDA 510(k) K812329 · Amf Biological and Diagnostics Co.
510(k) numberK812329
Submission
- Device name
- Zeta-Sera D
- Applicant
- Amf Biological and Diagnostics Co.
Mchenry, IL, US - Received
- August 18, 1981
- Decision date
- September 1, 1981
- 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 |
|---|---|---|
| K852418 | QCM-SP1(NORMAL Concenttration) & SP2(ABNORMAL)JJY · Traditional | 07/15/1985SE |
| K821931 | Zeta-CortCGR · Traditional | 07/22/1982SE |
| K821554 | Zetaphase T4 Radioimmunoassay Diag. KitCDX · Traditional | 06/25/1982SE |
| K821553 | Zetaphase T3 Uptake Diagnostic KitKHQ · Traditional | 06/25/1982SE |
Questions and answers
When was Zeta-Sera D cleared by the FDA?
Zeta-Sera D (K812329) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 14 days after the submission was received.
What is the product code of K812329?
The FDA product code is KIS – Sera, Animal And Human, a Class I (low risk) device regulated under 21 CFR 864.2800.