510(k) K170232 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
| Applicant | Boditech Med, Inc., Chuncheon-Si, KR |
| Decision | Substantially Equivalent, Oct 13, 2017 |
| Received | Jan 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170232
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.