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

Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase

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

JMB is the FDA product code for Visual, Semi-Quant. (Colorimetric), 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
JMB
Device name
Visual, Semi-Quant. (Colorimetric), 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 JMB

By decision year
1 clearance under product code JMB with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JMB by decision year
YearClearances
19851

Applicants with the most clearances

Product code JMB
Applicants holding the most 510(k) clearances under product code JMB
ApplicantClearances
Hybritech, 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 JMB.