ST-4 COAGULATION INSTRUMENT— 510(k) K904297

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K904297 for ST-4 COAGULATION INSTRUMENT, Substantially Equivalent on 1990-11-13. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant
American Bioproducts Co.
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
Parsippany, NJ, US
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