510(k) K031784 ยท GTY Antigens, All Groups, Streptococcus Spp.
ACON STREP A RAPID TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 14, 2003 |
| Received | Jun 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2012 | Alere San Diego Strep A Rapid Test Cassette (K031784), IST-502 Cassettes.
Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Terminated |
GTY | None listed |
| Feb 22, 2011 | Biosite Inc Dba Innovacon Inc. SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037
The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from Terminated |
GTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.