The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Automated Chemiluminescence System (asc) Centaur Analyzer.
| Device ID | K971418 |
| 510k Number | K971418 |
| Device Name: | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER |
| 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 | 1997-04-16 |
| Decision Date | 1997-07-17 |
| Summary: | summary |