510(k) K003696 ยท DHA System, Test, Human Chorionic Gonadotropin
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 25, 2001 |
| Received | Nov 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic. Terminated |
DHA | None listed |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic. Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.