DeviceClearance

THROMBELASTOGRAPH(R)— 510(k) K895844

Substantially Equivalent

Haemoscope Corp.

FDA 510(k) clearance K895844 for THROMBELASTOGRAPH(R), Substantially Equivalent on 1989-10-24. 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
Morton Grove, IL, US
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