K043451

Substantially Equivalent

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR

Applicant: Hyphen Biomed
Product code: GGN
Advisory panel: Hematology
Date received: 2004-12-14
Decision date: 2005-03-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mason, OH, US

Download summary PDF View on FDA.gov ↗

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