ALPHA-AMYLASE TEST— 510(k) K860665

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K860665 for ALPHA-AMYLASE TEST, Substantially Equivalent on 1986-04-07. Applicant: Sclavo, Inc..

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1986-02-24
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

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