DeviceClearance

COAG-A-MATE X2— 510(k) K813564

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K813564 for COAG-A-MATE X2, Substantially Equivalent on 1982-01-28. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant
General Diagnostics
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
Walker, MI, US
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