K864893 is an FDA 510(k) clearance for the ANTI-CYTOKERATIN MONOCLONAL ANTIBODY. This device is classified as a Cytokeratins (Class II - Special Controls, product code LYE).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 7, 1988, 570 days after receiving the submission on December 15, 1986.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K864893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1986 |
| Decision Date | July 07, 1988 |
| Days to Decision | 570 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LYE — Cytokeratins |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |