510(k) K080552 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
CYTO-CHEX BCT
| Applicant | Streck, La Vista NE, US |
| Decision | Substantially Equivalent, Jul 31, 2008 |
| Received | Feb 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2017 | Streck Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck. Open, Classified |
GIM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.