The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Magic Lite Tsh (hs) Immunoassay.
| Device ID | K912583 |
| 510k Number | K912583 |
| Device Name: | MAGIC LITE TSH (HS) IMMUNOASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-08-12 |