KQP — Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase Class II
FDA Device Classification
Classification Details
- Product Code
- KQP
- Device Class
- Class II
- Regulation Number
- 862.1315
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K102643 | astoria-pacific | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT | July 15, 2011 |
| K101392 | astoria-pacific | NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D | February 4, 2011 |
| K100101 | perkinelmer | GSP NEONATALGALT KIT, MODEL 3303-001U | June 11, 2010 |
| K993536 | bio-rad | BIO-RAD CODA NEONATAL GALT ASSAY | November 4, 1999 |
| K990827 | bio-rad | MICROPLATE NEONATAL GALT ASSAY | April 9, 1999 |
| K970277 | astoria-pacific | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) | December 11, 1997 |
| K894011 | alpkem | TOTAL GALACTOSE | January 11, 1990 |