ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL— 510(k) K873250

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K873250 for ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL, Substantially Equivalent on 1987-10-20. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 1987-08-17
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belleville, NJ, US

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