K964351 is an FDA 510(k) clearance for the ELECSYS PSA ASSAY. This device is classified as a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II - Special Controls, product code LTJ).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 25, 1997, 266 days after receiving the submission on November 1, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K964351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1996 |
| Decision Date | July 25, 1997 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |