The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Thyroid Stimulating Hormone (tsh-3) Immunoassay.
| Device ID | K951796 |
| 510k Number | K951796 |
| Device Name: | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Steven R Rakitin |
| Correspondent | Steven R Rakitin CIBA CORNING DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1995-06-13 |