510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121610Substantially Equivalent

Cobas C 501 Tina-Quant Hba1cdx Gen.3 Assay

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121610 is the FDA 510(k) clearance record for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY, a class II device, cleared for Roche Diagnostics Operations 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 465 510(k) clearances for ROCHE DIAGNOSTICS GMBH, from to . As of , FDA records show no recalls naming K121610.

Clearance record

Decision date
Received
(433 days to decision)
Product code
PDJ Hemoglobin A1c Test System
Regulation
21 CFR 862.1373
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Operations 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDJ

Trailing 12 months
2 clearances 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 20261