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 |