510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K100130Substantially Equivalent

Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2

Mitsubishi Chemical Medience Corporation, Baldwin MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100130 is the FDA 510(k) clearance record for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2, a class II device, cleared for Mitsubishi Chemical Medience CO on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 3 510(k) clearances for Mitsubishi Chemical Medience CO, from to . As of , FDA records show no recalls naming K100130.

Clearance record

Decision date
Received
(482 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Mitsubishi Chemical Medience CO P.O.Box 103, Baldwin MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMI

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