DeviceClearance

THROMBELASTOGRAPH COAGULATION ANALYZER 3000S— 510(k) K954437

Substantially Equivalent

Haemoscope Corp.

FDA 510(k) clearance K954437 for THROMBELASTOGRAPH COAGULATION ANALYZER 3000S, Substantially Equivalent on 1996-01-30. Applicant: Haemoscope Corp.. Device class: 2.

Clearance details

Applicant
Haemoscope Corp.
Product code
Code GKP
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Skokie, IL, US
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