ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY— 510(k) K900718

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K900718 for ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY, Substantially Equivalent on 1990-06-12. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 1990-02-14
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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