Atlas FDA

KQE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7360
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
GLUCOSE-6-PHOSPHATE DEHYDROGENASE (K823900)Alladin Diagnostic, Inc.1983-02-07

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