K974189 is an FDA 510(k) clearance for the ELECSYS PSA (ON ELECSYS 1010). 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. (Pleasanton, US). The FDA issued a Cleared decision on January 6, 1998, 60 days after receiving the submission on November 7, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K974189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1997 |
| Decision Date | January 06, 1998 |
| Days to Decision | 60 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 |