MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658— 510(k) K011145

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K011145 for MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658, Substantially Equivalent on 2001-06-25. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2001-03-26
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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