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

Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase

21 CFR 864.7360 / Hematology
FDA source (opens on fda.gov)

JLM is the FDA product code for Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase, a class II device type, regulated under 21 CFR 864.7360. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JLM
Device name
Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code JLM

By decision year
1 clearance under product code JLM with a decision year between 1987 and 1987, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JLM by decision year
YearClearances
19871

Applicants with the most clearances

Product code JLM
Applicants holding the most 510(k) clearances under product code JLM
ApplicantClearances
Boots-Celltech 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 JLM.