510(k) K001552 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
TREPCHEK TREPONEMAL ANTIBODY EIA
| Applicant | Phoenix Biotech Corp., Blairstown NJ, US |
| Decision | Substantially Equivalent, Oct 19, 2000 |
| Received | May 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2005 | Diasorin Inc. Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Terminated |
LIP | None listed |
| Dec 17, 2004 | Diamedix Corporation The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be u Terminated |
LIP | None listed |
| Jul 20, 2004 | Diamedix Corporation Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 3 Terminated |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.