DeviceClearance

Product code PDJ— Clinical Chemistry

ADAMS A1c HA-8180V, CALIBRATOR 80

Classification name
Hemoglobin A1c Test System
Device class
Class 2
Regulation
21 CFR 862.1373
Advisory panel
Clinical Chemistry
Total cleared
26
First cleared
Most recent

FDA classification definition

“Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.”

— U.S. Food and Drug Administration, device classification record for product code PDJ under 21 CFR 862.1373, via openFDA

Market context for product code PDJ

FDA has cleared 26 devices under product code PDJ between 2013 and 2026, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PDJ

Recent clearances under product code PDJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.