Atlas FDA

JBL

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7360
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (K990957)Astoria-Pacific, Inc.1999-05-11
DEHYDROGENOSE, GLUCOSE PHOSPHATE (K790211)Sigma Chemical Co.1979-03-15

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Every clearance here is in the API, with alerts when new ones post.