K051472

Substantially Equivalent

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR

Applicant: Hyphen Biomed
Product code: GGN
Advisory panel: Hematology
Date received: 2005-06-03
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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