K782156 is an FDA 510(k) clearance for the UNITEST CREATINE KINASE. This device is classified as a Atp And Creatine Kinase (enzymatic), Creatine (Class I - General Controls, product code JLB).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on March 2, 1979, 70 days after receiving the submission on December 22, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1210.
| 510(k) Number | K782156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1978 |
| Decision Date | March 02, 1979 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JLB — Atp And Creatine Kinase (enzymatic), Creatine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1210 |