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

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

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

JMK is the FDA product code for Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase, a class I device type, regulated under 21 CFR 862.1380. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JMK
Device name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
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
16
Ingested recalls
0

Clearances, product code JMK

By decision year
16 clearances under product code JMK with a decision year between 1976 and 1999, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JMK by decision year
YearClearances
19761
19773
19784
19822
19841
19861
19951
19961
19992

Applicants with the most clearances

Product code JMK
Applicants holding the most 510(k) clearances under product code JMK
ApplicantClearances
Harleco4
Medical Analysis Systems, Inc.2
Polymer Technology Systems2
Beckman Instruments, Inc.1
Gilford Diagnostics1
Harleco Diagnostics1
Ihara Medics U.S., Inc.1
Instrumentation Laboratory Co.1
Reagents Applications, Inc.1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code