AMYLASE EPS REAGENT— 510(k) K070064

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K070064 for AMYLASE EPS REAGENT, Substantially Equivalent on 2007-05-22. Applicant: Thermo Fisher Scientific.

Clearance details

Applicant: Thermo Fisher Scientific
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2007-01-05
Decision date: 2007-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noble Park, AU

Download summary PDF View on FDA.gov ↗

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