510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142595Substantially Equivalent

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

Ortho-Clinical Diagnostics, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142595 is the FDA 510(k) clearance record for VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II, a class II device, cleared for Ortho Clinical Diagnostics 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 311 510(k) clearances for Ortho Clinical Diagnostics, from to . As of , FDA records show 2 recalls naming K142595.

Clearance record

Decision date
Received
(262 days to decision)
Product code
PDJ Hemoglobin A1c Test System
Regulation
21 CFR 862.1373
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho Clinical Diagnostics 100 Indigo Creek Dr., Rochester NY
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