510(k) K980507 ยท GMZ Antigens, All Types, Escherichia Coli
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
| Applicant | Alexon - Trend, Inc., Ramsey MN, US |
| Decision | Substantially Equivalent, Apr 23, 1998 |
| Received | Feb 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Remel, Inc. ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of Terminated |
GMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.