Submission Details
| 510(k) Number | K872847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 20, 1987 |
| Decision Date | August 10, 1987 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K872847 is an FDA 510(k) clearance for the SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT, a Sera, Animal And Human (Class I — General Controls, product code KIS), submitted by Candace Lane Corp. (Parsippany, US). The FDA issued a Cleared decision on August 10, 1987, 21 days after receiving the submission on July 20, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2800.
| 510(k) Number | K872847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 20, 1987 |
| Decision Date | August 10, 1987 |
| Days to Decision | 21 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 |