510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003064Substantially Equivalent

Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323

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

K003064 is the FDA 510(k) clearance record for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DDG (Transferrin, Antigen, Antiserum, Control). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show 3 recalls naming K003064.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DDG Transferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5880
Device class
Class II
Review panel
Immunology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code DDG

Trailing 12 months

FDA records hold no clearances under product code DDG in the trailing twelve months.

FDA records show no clearances under product code DDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260