ROTACHROM HBPM/LMWH TEST KIT— 510(k) K943516

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K943516 for ROTACHROM HBPM/LMWH TEST KIT, Substantially Equivalent on 1995-08-31. Applicant: American Bioproducts Co..

Clearance details

Applicant: American Bioproducts Co.
Product code: Code KFF
Advisory panel: Hematology
Date received: 1994-07-21
Decision date: 1995-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.