ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL— 510(k) K964422

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K964422 for ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL, Substantially Equivalent on 1996-11-25. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIF
Advisory panel: Clinical Toxicology
Date received: 1996-11-05
Decision date: 1996-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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