510(k) K061889 ยท GMZ Antigens, All Types, Escherichia Coli
BIOSTAR OIA SHIGATOX
| Applicant | Inverness Medical-Biostar, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Dec 12, 2006 |
| Received | Jul 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2017 | Advanced Sterilization Products EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004
The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant C Terminated |
FEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.