MICROSAMPLE COAGULATION ANALYZER— 510(k) K943153

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K943153 for MICROSAMPLE COAGULATION ANALYZER, Substantially Equivalent on 1995-03-24. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant
Bio/Data 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
Horsham, PA, US
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