KQP
7 FDA 510(k) clearances · Product code
219 daysmedian time to decision
322 days90th percentile
7clearances measured
FDA profile
- Official device name
- Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1315
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (K102643) | Astoria-Pacific, Inc. | 2011-07-15 |
| NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (K101392) | Astoria-Pacific, Inc. | 2011-02-04 |
| GSP NEONATALGALT KIT, MODEL 3303-001U (K100101) | Perkinelmer, Inc. | 2010-06-11 |
| BIO-RAD CODA NEONATAL GALT ASSAY (K993536) | Bio-Rad | 1999-11-04 |
| MICROPLATE NEONATAL GALT ASSAY (K990827) | Bio-Rad | 1999-04-09 |
| URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277) | Astoria-Pacific, Inc. | 1997-12-11 |
| TOTAL GALACTOSE (K894011) | Alpkem Corp. | 1990-01-11 |
Track KQP automatically
Every clearance here is in the API, with alerts when new ones post.