FDA Product Code
FDA Product Code KQP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1315
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102643 | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2011-07-15 | Traditional | PDF ↗ |
| K101392 | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | Astoria-Pacific, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | Perkinelmer, Inc. | 2010-06-11 | Traditional | PDF ↗ |
| K993536 | BIO-RAD CODA NEONATAL GALT ASSAY | Bio-Rad | 1999-11-04 | Special | PDF ↗ |
| K990827 | MICROPLATE NEONATAL GALT ASSAY | Bio-Rad | 1999-04-09 | Special | PDF ↗ |
| K970277 | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | Astoria-Pacific, Inc. | 1997-12-11 | Traditional | PDF ↗ |
| K894011 | TOTAL GALACTOSE | Alpkem Corp. | 1990-01-11 | Traditional | PDF ↗ |
Product code KQP · Class II · Clinical Chemistry. Data: openFDA.