510(k) K905661 ยท CEK Biuret (Colorimetric), Total Protein
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 31, 1991 |
| Received | Dec 18, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905661
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.