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

System, Analysis, Electrophoretic Hemoglobin

21 CFR 864.7440 / Hematology
FDA source (opens on fda.gov)

JBD is the FDA product code for System, Analysis, Electrophoretic Hemoglobin, a class II device type, regulated under 21 CFR 864.7440. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JBD
Device name
System, Analysis, Electrophoretic Hemoglobin
Regulation
21 CFR 864.7440
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
26
Ingested recalls
3

Clearances, product code JBD

By decision year
26 clearances under product code JBD with a decision year between 1977 and 2006, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code JBD by decision year
YearClearances
19771
19783
19793
19806
19813
19821
19831
19901
19932
19981
19992
20041
20061

Applicants with the most clearances

Product code JBD
Applicants holding the most 510(k) clearances under product code JBD
ApplicantClearances
Helena Laboratories, Corp.11
Corning Medical & Scientific3
Beckman Instruments, Inc.2
Electrophoresis Corp. of America2
Gelman Sciences, Inc.2
Interlab S.r.l.2
Isolab, Inc.2
Miles Laboratories, Inc.1
Morax1

Companies listing this code with FDA

Companies whose registered establishments list this code