510(k) K971353 ยท CFL Radioimmunoassay, Human Growth Hormone
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, May 12, 1997 |
| Received | Apr 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971353
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.