510(k) K970277 ยท KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
| Applicant | Astoria-Pacific, Inc., Clackamas OR, US |
| Decision | Substantially Equivalent, Dec 11, 1997 |
| Received | Jan 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2015 | Siemens Medical Solutions Diagnostics Liquid Waste Bottle, Catalog#10291587.
The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine sam Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.