The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Phenytoin Assay.
Device ID | K955873 |
510k Number | K955873 |
Device Name: | ACS PHENYTOIN ASSAY |
Classification | Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) |
Applicant | CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
Contact | Steven R Rakitin |
Correspondent | Steven R Rakitin CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 -1688 |
Product Code | LGR |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-26 |
Decision Date | 1996-03-11 |