The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Corporation Acs: Centaur Br Immunoassay.
| Device ID | K982680 |
| 510k Number | K982680 |
| Device Name: | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY |
| Classification | System, Test, Immunological, Antigen, Tumor |
| 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 | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-31 |
| Decision Date | 1998-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598420 | K982680 | 000 |
| 00630414294056 | K982680 | 000 |
| 00630414182247 | K982680 | 000 |
| 00630414182254 | K982680 | 000 |
| 00630414182261 | K982680 | 000 |
| 00630414194707 | K982680 | 000 |
| 00630414196657 | K982680 | 000 |
| 00630414196664 | K982680 | 000 |
| 00630414196688 | K982680 | 000 |
| 00630414204772 | K982680 | 000 |
| 00630414598048 | K982680 | 000 |
| 00630414598055 | K982680 | 000 |
| 00630414598062 | K982680 | 000 |
| 00630414598079 | K982680 | 000 |
| 00630414294049 | K982680 | 000 |