510(k) K953211 ยท CIJ Saccharogenic, Amylase
AMYLASE (ETHYLIDENE PNGPG7) KIT
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Jun 21, 1996 |
| Received | Jul 10, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953211
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | RANDOX LABORATORIES, LTD. Amylase AY3805 batch 480449
Amylase Ethylidene Blocked-pNPG7 Reagent Terminated |
CIJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.