510(k) K042241 ยท DGC Ige, Antigen, Antiserum, Control
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
| Applicant | Kamiya Biomedical Co., Tukwila WA, US |
| Decision | Substantially Equivalent, Dec 10, 2004 |
| Received | Aug 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042241
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.