510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031739Substantially Equivalent

I-Stat Cardiac Troponin (Ctni) Test

I-Stat Corp., East Windsor NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031739 is the FDA 510(k) clearance record for I-STAT CARDIAC TROPONIN (CTNI) TEST, a class II device, cleared for I-Stat Corporation on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 21 510(k) clearances for I-Stat Corporation, from to . As of , FDA records show 5 recalls naming K031739.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
I-Stat Corporation 104 Windsor Center Dr., East Windsor NJ
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