Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

FDA product code JBL · Class II (moderate risk) · 21 CFR 864.7360 · Hematology

2510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K990957Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KJBL · Traditional Astoria-Pacific, Inc.05/11/1999SE
K790211Dehydrogenose, Glucose PhosphateJBL · Traditional Sigma Chemical Co.03/15/1979SE

Recalls

RecallProductFirmInitiated
Z-1255-2019 Class IIG-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This…The target values and ranges in these lots are incorrect. Randox Laboratories Ltd.04/03/2019Terminated
Z-1254-2019 Class IIG-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage:…The target values and ranges in these lots are incorrect. Randox Laboratories Ltd.04/03/2019Terminated