Product code JIA— Clinical Chemistry
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
- Classification name
- Enzymatic Methods, Galactose
- Device class
- Class 1
- Regulation
- 21 CFR 862.1310
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code JIA
FDA has cleared devices under product code JIA between 1995 and 2019, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2019
- 2014
- 2013
- 2008
- 1999
- 1996
- 1995
Top applicants under product code JIA
Recent clearances under product code JIA
- K190335 — GSP Neonatal Total Galactose kit
- K133652 — GSP NEONATAL TOTAL GALACTOSE KIT
- K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
- K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
- K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY
- K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
- K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
- K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
- K951329 — IMMUCHEM GAL-MW EA
Data sourced from openFDA. This site is unofficial and independent of the FDA.