510(k) K972155 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE (CK)
| Applicant | Stanbio Laboratory, San Antonio TX, US |
| Decision | Substantially Equivalent, Jul 17, 1997 |
| Received | Jun 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972155
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Medtest Holdings, Inc. Pointe Scientific Liquid Creatine Kinase Reagent Set
Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of cre Terminated |
CGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.