K964368 is an FDA 510(k) clearance for the ELECSYS CEA ASSAY. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 16, 1997, 227 days after receiving the submission on November 1, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K964368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1996 |
| Decision Date | June 16, 1997 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |