510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182988Substantially Equivalent

Afinion HbA1c Dx on Afinion 2

Alere Technologies AS, Oslo, NO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182988 is the FDA 510(k) clearance record for Afinion HbA1c Dx on Afinion 2, a class II device, cleared for Alere Technologies AS on under FDA product code PDJ (Hemoglobin A1c Test System). FDA's definition for product code PDJ reads: "Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes". FDA records list 3 510(k) clearances for Alere Technologies AS, from to . As of , FDA records show one recall naming K182988.

Clearance record

Decision date
Received
(31 days to decision)
Product code
PDJ Hemoglobin A1c Test System
Regulation
21 CFR 862.1373
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alere Technologies AS Kjelsaasveien 161, Oslo, NO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDJ

Trailing 12 months
1 clearance under product code PDJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PDJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260