The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs:centaur Psa2 Immunoassay.
| Device ID | K981839 |
| 510k Number | K981839 |
| Device Name: | ACS:CENTAUR PSA2 IMMUNOASSAY |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-08-12 |
| Summary: | summary |