MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE— 510(k) K983704

Name: FDA 510(k) clearance K983704
Creator: U.S. Food and Drug Administration
Published: 1999-02-10

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983704 for MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE, Substantially Equivalent on 1999-02-10. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 1998-10-21
Decision date: 1999-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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