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 |