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
K072189Substantially Equivalent

Pathfast Ntprobnp and D-Dimer Tests

Mitsubishi Kagaku Iatron, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K072189 is the FDA 510(k) clearance record for PATHFAST NTPROBNP AND D-DIMER TESTS, a class II device, cleared for Mitsubishi Kagaku Iatron on under FDA product code NBC (Test, Natriuretic Peptide). FDA records list 4 510(k) clearances for Mitsubishi Kagaku Iatron, from to . As of , FDA records show one recall naming K072189.

Clearance record

Decision date
Received
(183 days to decision)
Product code
NBC Test, Natriuretic Peptide
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Mitsubishi Kagaku Iatron 701 Fifth Ave., Floor 42, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code NBC

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