510(k) K971825 ยท JFJ Catalytic Methods, Amylase
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Jul 24, 1997 |
| Received | May 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | RANDOX LABORATORIES, LTD. Pancreatic Amylase AY3855 batch 480483
Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent Terminated |
JFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.