510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K033491Substantially Equivalent

Roche Diagnostics Cardiac D-Dimer Rapid Assay; Roche Diagnostics Cardiac D-Dimer Controls

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

K033491 is the FDA 510(k) clearance record for ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K033491.

Clearance record

Decision date
Received
(302 days to decision)
Product code
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DAP

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