K002376 is an FDA 510(k) clearance for the ADVIA: CENTAUR AND ACS: 180 CPSA 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 Bayer Corp. (Medfield, US). The FDA issued a Cleared decision on October 26, 2000, 83 days after receiving the submission on August 4, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K002376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2000 |
| Decision Date | October 26, 2000 |
| Days to Decision | 83 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 |