510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JKFClass I

Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge

21 CFR 862.1380 / Clinical Chemistry
FDA source (opens on fda.gov)

JKF is the FDA product code for Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge, a class I device type, regulated under 21 CFR 862.1380. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JKF
Device name
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
Regulation
21 CFR 862.1380
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JKF

By decision year
2 clearances under product code JKF with a decision year between 1984 and 1986, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JKF by decision year
YearClearances
19841
19861

Applicants with the most clearances

Product code JKF
Applicants holding the most 510(k) clearances under product code JKF
ApplicantClearances
Sterling Biochemical, Inc.1
Sterling Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JKF.