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JBL — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative Class II

FDA Device Classification

FDA product code JBL covers "Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative", a Class II medical device regulated under 21 CFR 864.7360. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JBL
Device Class
Class II
Regulation Number
864.7360
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K990957astoria-pacificASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13KMay 11, 1999
K790211sigma chemicalDEHYDROGENOSE, GLUCOSE PHOSPHATEMarch 15, 1979

FDA data resources