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JKF

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
Device class
Class I (low risk)
Regulation
21 CFR 862.1380
Medical specialty
Clinical Chemistry
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RecordFirmDate
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (K861855)Sterling Diagnostics, Inc.1986-06-16
HYDROXYBUTYRATE DEHYDROGENASE REAGENT (K834084)Sterling Biochemical, Inc.1984-02-04

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