510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954437Substantially Equivalent

Thrombelastograph Coagulation Analyzer 3000S

Haemoscope Corp., Skokie IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954437 is the FDA 510(k) clearance record for THROMBELASTOGRAPH COAGULATION ANALYZER 3000S, a class II device, cleared for Haemoscope Corp. on under FDA product code GKP (Instrument, Coagulation, Automated). FDA records list 7 510(k) clearances for Haemoscope Corp., from to . As of , FDA records show no recalls naming K954437.

Clearance record

Decision date
Received
(130 days to decision)
Product code
GKP Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Haemoscope Corp. 7855 Gross Pt. Rd., Skokie IL
510(k) summary
Summary
Third party review
No

Clearances, product code GKP

Trailing 12 months

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

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