ONTRAK TESTCUP AND TESTSTIK CONTROLS— 510(k) K983387

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983387 for ONTRAK TESTCUP AND TESTSTIK CONTROLS, Substantially Equivalent on 1998-10-09. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 1998-09-25
Decision date: 1998-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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