The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Ck-isozyme U.v. Reagent Set.
| Device ID | K823550 |
| 510k Number | K823550 |
| Device Name: | CK-ISOZYME U.V. REAGENT SET |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-30 |
| Decision Date | 1983-01-07 |