K870469 is an FDA 510(k) clearance for the DEFINED EQUINE SERUM #A-3311. This device is classified as a Sera, Animal And Human (Class I - General Controls, product code KIS).
Submitted by Hyclone Laboratories, Inc. (Logan, US). The FDA issued a Cleared decision on March 24, 1987, 49 days after receiving the submission on February 3, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2800.
| 510(k) Number | K870469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1987 |
| Decision Date | March 24, 1987 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIS — Sera, Animal And Human |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2800 |