ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION— 510(k) K972891

Name: FDA 510(k) clearance K972891
Creator: U.S. Food and Drug Administration
Published: 1997-10-01

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K972891 for ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION, Substantially Equivalent on 1997-10-01. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1997-08-05
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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