Company ยท US
Astoria-Pacific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2013. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 3 |
| NAK | System, Test, Biotinidase | 2 |
| CDR | 1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine | 1 |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | 1 |
| JIA | Enzymatic Methods, Galactose | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2013 | K121101 | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | JIA |
| Jul 15, 2011 | K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | KQP |
| Feb 4, 2011 | K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D Astoria-Pacific, Inc. | KQP |
| Dec 14, 2009 | K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED Astoria-Pacific, Inc. | JJT |
| Nov 4, 2008 | K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT Astoria-Pacific, Inc. | NAK |
| Sep 21, 2001 | K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K Astoria-Pacific, Inc. | NAK |
| May 11, 1999 | K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K Astoria-Pacific, Inc. | JBL |
| Mar 19, 1998 | K970093 | TYROSINE 50-HOUR REAGENT KIT Astoria-Pacific, Inc. | CDR |
| Dec 11, 1997 | K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) Astoria-Pacific, Inc. | KQP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||