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

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

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

JBF is the FDA product code for Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening, a class II device type, regulated under 21 CFR 864.7360. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JBF
Device name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
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
5
Ingested recalls
1

Clearances, product code JBF

By decision year
5 clearances under product code JBF with a decision year between 1995 and 2022, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JBF by decision year
YearClearances
19951
20031
20081
20161
20221

Applicants with the most clearances

Product code JBF
Applicants holding the most 510(k) clearances under product code JBF
ApplicantClearances
Alere Scarborough, Inc.1
Baebies Inc.1
Binax, Inc.1
Horiba Instruments Incorporated1
Sigma Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code