The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Ckmb Immunoassay.
| Device ID | K911121 |
| 510k Number | K911121 |
| Device Name: | CIBA CORNING ACS CKMB IMMUNOASSAY |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-12 |
| Decision Date | 1991-04-03 |