The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Chiron Diagnostics Acs: 180 Carbamazepine Assay.
| Device ID | K964765 |
| 510k Number | K964765 |
| Device Name: | CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY |
| Classification | Enzyme Immunoassay, Carbamazepine |
| 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 | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598482 | K964765 | 000 |
| 00630414527178 | K964765 | 000 |
| 00630414527161 | K964765 | 000 |
| 00630414527154 | K964765 | 000 |
| 00630414527147 | K964765 | 000 |
| 00630414527130 | K964765 | 000 |