510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071319Substantially Equivalent

I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02

Bio-Rad, Diagnostics Grp., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071319 is the FDA 510(k) clearance record for I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02, a class II device, cleared for Bio-Rad, Diagnostics Grp. on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 6 510(k) clearances for Bio-Rad, Diagnostics Grp., from to . As of , FDA records show no recalls naming K071319.

Clearance record

Decision date
Received
(47 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad, Diagnostics Grp. 9500 Jeronimo Rd., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGN

Trailing 12 months

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

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