510(k) K023766 ยท GTY Antigens, All Groups, Streptococcus Spp.
ACON STREP A TWIST TEST DEVICE
| Applicant | Acon Laboratories Co., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 10, 2003 |
| Received | Nov 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2012 | Alere San Diego Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes.
Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Terminated |
GTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.