510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K033612Substantially Equivalent

Factor II (Prothrombin) G20210a Kit

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

K033612 is the FDA 510(k) clearance record for FACTOR II (PROTHROMBIN) G20210A KIT, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr). FDA's definition for product code NPR reads: "In vitro diagnostic test to detect the Factor II G20210A 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 2 recalls naming K033612.

Clearance record

Decision date
Received
(31 days to decision)
Product code
NPR Test, Factor Ii G20210a 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
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPR

Trailing 12 months

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

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