Fetal Bovine Serum, F4884 Sterile Growt
FDA 510(k) K843629 · Sigma Chemical Co.
510(k) numberK843629
Submission
- Device name
- Fetal Bovine Serum, F4884 Sterile Growt
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- September 14, 1984
- Decision date
- October 1, 1984
- 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 |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Fetal Bovine Serum, F4884 Sterile Growt cleared by the FDA?
Fetal Bovine Serum, F4884 Sterile Growt (K843629) received a 510(k) decision of Substantially Equivalent on October 1, 1984, 17 days after the submission was received.
What is the product code of K843629?
The FDA product code is KIS – Sera, Animal And Human, a Class I (low risk) device regulated under 21 CFR 864.2800.