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

Hemoglobin A1c Test System

21 CFR 862.1373 / Clinical Chemistry
FDA source (opens on fda.gov)

PDJ is the FDA product code for Hemoglobin A1c Test System, a class II device type, regulated under 21 CFR 862.1373. FDA's definition for this code reads: "Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes". As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
PDJ
Device name
Hemoglobin A1c Test System
FDA definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Regulation
21 CFR 862.1373
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
9

Clearances, product code PDJ

By decision year
26 clearances under product code PDJ with a decision year between 2013 and 2026, 2018 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code PDJ by decision year
YearClearances
20132
20142
20154
20162
20173
20185
20191
20201
20212
20241
20252
20261

Applicants with the most clearances

Product code PDJ
Applicants holding the most 510(k) clearances under product code PDJ
ApplicantClearances
Bio-Rad Laboratories Inc.3
Siemens Healthcare Diagnostics Inc.3
Tosoh Bioscience Inc3
Abbott Medical2
Alere Technologies AS2
Roche Diagnostics GmbH2
Roche Diagnostics Operations (Rdo)2
Sebia, Inc.2
Shanghai Medconn Medical Technology Co., Ltd.2
ARKRAY Factory, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order