REDI-TEST OPIATES— 510(k) K991883

Substantially Equivalent

Advantage Diagnostics Corp.

FDA 510(k) clearance K991883 for REDI-TEST OPIATES, Substantially Equivalent on 1999-09-15. Applicant: Advantage Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Advantage Diagnostics Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1999-06-02
Decision date: 1999-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.