K071319

Substantially Equivalent

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

Applicant: Bio-Rad, Diagnostics Grp.
Product code: GGN
Advisory panel: Hematology
Date received: 2007-05-10
Decision date: 2007-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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