510(k) K953362 ยท GNA Antisera, All Types, Escherichia Coli
PREMIER EHEC
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 14, 1995 |
| Received | Jul 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2017 | Meridian Bioscience Inc PREMIER EHEC and PREMIER EHEC Bulk. Terminated |
GNA | None listed |
| Nov 17, 2011 | Meridian Bioscience Inc EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4- Terminated |
LFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.