Alphacalf Serum
FDA 510(k) K884654 · Hyclone Laboratories, Inc.
510(k) numberK884654
Submission
- Device name
- Alphacalf Serum
- Applicant
- Hyclone Laboratories, Inc.
Logan, UT, US - Received
- November 7, 1988
- Decision date
- November 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIT – Media And Components, Synthetic Cell And Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2220
- Specialty
- Hematology
Other 510(k)s with product code KIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K892938 | Amnio-Grow TMKIT · Traditional | Inovar Biologicals, Inc. | 05/22/1989SE |
| K890701 | Endothelial Growth Medium (Egm)KIT · Traditional | Clonetics Corp. | 02/24/1989SE |
| K890700 | Melanocyte Growth Medium (MGM)KIT · Traditional | Clonetics Corp. | 02/24/1989SE |
| K890482 | Abc, ABC-1X, Abc(Tm)KIT · Traditional | Cell Ent., Inc. | 02/10/1989SE |
| K884574 | Dme & Ham's Nutrient Mixture, Prod. No. D9785KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K884573 | HBSS W/O Calc Chlor/Mag Sulf/Phen Red/Sb No. H4891KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K884572 | RPMI-1640 Hybri-Max, Prod. No. R5382KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K883065 | Alloprep SystemKIT · Traditional | Osteotech, Inc. | 10/13/1988SE |
| K884031 | FBS, Eq., or Fetal Bovine Serum EquivalentKIT · Traditional | Regency Biotech | 10/06/1988SE |
| K883951 | Medium 199 W/Ebss (Catalog No. 200-2037)KIT · Traditional | J R Scientific | 09/30/1988SE |
More from J R Scientific
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K870466 | Defined Calf Bovine Serum #A-2111KIS · 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 Alphacalf Serum cleared by the FDA?
Alphacalf Serum (K884654) received a 510(k) decision of Substantially Equivalent on November 30, 1988, 23 days after the submission was received.
What is the product code of K884654?
The FDA product code is KIT – Media And Components, Synthetic Cell And Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2220.