ABUSCREEN FP FOR CANNABINOIDS (15-50)— 510(k) K910592

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K910592 for ABUSCREEN FP FOR CANNABINOIDS (15-50), Substantially Equivalent on 1991-06-21. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant
Roche Diagnostic Systems, Inc.
Product code
Code LDJ
Device class
Class 2
Regulation
21 CFR 862.3870
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montclair, NJ, US
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