The following data is part of a premarket notification filed by Biorent Diagnostic, Inc. with the FDA for Ck-uv Reagent.
| Device ID | K823211 |
| 510k Number | K823211 |
| Device Name: | CK-UV REAGENT |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | BIORENT DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-28 |
| Decision Date | 1982-11-22 |