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

Hemoglobin A2 Quantitation

21 CFR 864.7400 / Hematology
FDA source (opens on fda.gov)

JPD is the FDA product code for Hemoglobin A2 Quantitation, a class II device type, regulated under 21 CFR 864.7400. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
JPD
Device name
Hemoglobin A2 Quantitation
Regulation
21 CFR 864.7400
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
13
Ingested recalls
5

Clearances, product code JPD

By decision year
13 clearances under product code JPD with a decision year between 1980 and 2002, 1992 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JPD by decision year
YearClearances
19801
19812
19831
19881
19901
19911
19923
19931
19991
20021

Applicants with the most clearances

Product code JPD
Applicants holding the most 510(k) clearances under product code JPD
ApplicantClearances
Helena Laboratories, Corp.6
Bio-Rad4
Drew Scientific, Ltd.1
Isolab, Inc.1
Tosoh Medics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code