The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Cortisol Immunoassay.
| Device ID | K962559 |
| 510k Number | K962559 |
| Device Name: | ACS CORTISOL IMMUNOASSAY |
| Classification | Fluorometric, Cortisol |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Thomas F Flyn |
| Correspondent | Thomas F Flyn CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1996-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598673 | K962559 | 000 |
| 00630414524740 | K962559 | 000 |
| 00630414524610 | K962559 | 000 |
| 00630414524603 | K962559 | 000 |
| 00630414121819 | K962559 | 000 |