The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Alkaline Phosphatase Isoenzyme System.
| Device ID | K885024 |
| 510k Number | K885024 |
| Device Name: | ALKALINE PHOSPHATASE ISOENZYME SYSTEM |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | J Pignato |
| Correspondent | J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-02-17 |