VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY— 510(k) K010177

Substantially Equivalent

Sun Biomedical Laboratories, Inc.

FDA 510(k) clearance K010177 for VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY, Substantially Equivalent on 2001-05-17. Applicant: Sun Biomedical Laboratories, Inc..

Clearance details

Applicant: Sun Biomedical Laboratories, Inc.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2001-01-18
Decision date: 2001-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blackwood, NJ, US

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