Data / Medical devices / Hemoglobin A1c Test System

Hemoglobin A1c Test System (PDJ): 25 FDA-registered makers in 9 countries

25 establishments in 9 countries are registered with the FDA to make Hemoglobin A1c Test System (product code PDJ, Class 2, 21 CFR 862.1373). 16 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on October 2, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code

PDJ

Device class

2

Regulation

862.1373

Medical specialty

Clinical Chemistry

Makers by country

Makers of Hemoglobin A1c Test System

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.