Submission Details
| 510(k) Number | K854724 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 1985 |
| Decision Date | December 13, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K854724 is an FDA 510(k) clearance for the CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Lifetrac, Inc. (Washington, US). The FDA issued a Cleared decision on December 13, 1985, 21 days after receiving the submission on November 22, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K854724 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 1985 |
| Decision Date | December 13, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIZ — Dish, Tissue Culture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2240 |