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

Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

21 CFR 862.1445 / Clinical Chemistry
FDA source (opens on fda.gov)

JGF is the FDA product code for Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes, a class II device type, regulated under 21 CFR 862.1445. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JGF
Device name
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Regulation
21 CFR 862.1445
Device class
Class II
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
6
Ingested recalls
0

Clearances, product code JGF

By decision year
6 clearances under product code JGF with a decision year between 1986 and 1998, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JGF by decision year
YearClearances
19861
19871
19891
19911
19931
19981

Applicants with the most clearances

Product code JGF
Applicants holding the most 510(k) clearances under product code JGF
ApplicantClearances
Abbott Medical2
Em Diagnostic Systems, Inc.2
Alpkem Corp.1
Trace Scientific, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code