ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS— 510(k) K932548

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K932548 for ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS, Substantially Equivalent on 1993-12-29. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DLJ
Advisory panel: Clinical Toxicology
Date received: 1993-05-26
Decision date: 1993-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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