JKF · Class I · 21 CFR 862.1380

FDA Product Code JKF: Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge

Leading manufacturers include Sterling Biochemical, Inc. and Sterling Diagnostics, Inc..

2
Total
2
Cleared
51d
Avg days
1984
Since

FDA 510(k) Cleared Dinitrophenyl Hydrazone Measurement (colorimetric), Hydroxybutyric Dehydroge Devices (Product Code JKF)

2 devices
1–2 of 2
Cleared Jun 16, 1986
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855
Sterling Diagnostics, Inc.
Chemistry · 33d
Cleared Feb 04, 1984
HYDROXYBUTYRATE DEHYDROGENASE REAGENT
K834084
Sterling Biochemical, Inc.
Chemistry · 68d

About Product Code JKF - Regulatory Context