The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corining Acs Theophylline Immunoassay.
| Device ID | K951169 |
| 510k Number | K951169 |
| Device Name: | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| 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 | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-15 |
| Decision Date | 1995-06-20 |