ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS— 510(k) K912048

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K912048 for ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS, Substantially Equivalent on 1991-07-26. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DLJ
Advisory panel: Clinical Toxicology
Date received: 1991-05-09
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

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