Product code KQP— Clinical Chemistry
BIO-RAD CODA NEONATAL GALT ASSAY
- Classification name
- Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- Device class
- Class 2
- Regulation
- 21 CFR 862.1315
- Advisory panel
- Clinical Chemistry
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code KQP
FDA has cleared devices under product code KQP between 1990 and 2011, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2011
- 2010
- 1999
- 1997
- 1990
Top applicants under product code KQP
Recent clearances under product code KQP
- K102643 — SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
- K101392 — NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
- K100101 — GSP NEONATALGALT KIT, MODEL 3303-001U
- K993536 — BIO-RAD CODA NEONATAL GALT ASSAY
- K990827 — MICROPLATE NEONATAL GALT ASSAY
- K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
- K894011 — TOTAL GALACTOSE
Data sourced from openFDA. This site is unofficial and independent of the FDA.