510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN030005Unknown

Factor V Leiden Kit

Roche Diagnostics GmbH, Indianapolis IN / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN030005 is the FDA 510(k) clearance record for FACTOR V LEIDEN KIT, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr). FDA's definition for product code NPQ reads: "In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia". FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming DEN030005.

Clearance record

Decision date
Received
(9 days to decision)
Product code
NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code NPQ

Trailing 12 months

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

FDA records show no clearances under product code NPQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPQ, 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