The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Testosterone Immunoassay.
| Device ID | K934562 |
| 510k Number | K934562 |
| Device Name: | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| 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 | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-16 |
| Decision Date | 1993-12-10 |