510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020355Substantially Equivalent

I-Stat Prothrombin Time Test

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

K020355 is the FDA 510(k) clearance record for I-STAT PROTHROMBIN TIME TEST, a class II device, cleared for I-Stat Corporation on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 21 510(k) clearances for I-Stat Corporation, from to . As of , FDA records show 5 recalls naming K020355.

Clearance record

Decision date
Received
(99 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
I-Stat Corporation 104 Windsor Center Dr., East Windsor NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GJS

Trailing 12 months

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

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