MESACUP-2 TEST JO-1, MODEL 10756— 510(k) K033528

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K033528 for MESACUP-2 TEST JO-1, MODEL 10756, Substantially Equivalent on 2003-12-22. Applicant: Rhigene, Inc.. Device class: 2.

Clearance details

Applicant: Rhigene, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2003-11-07
Decision date: 2003-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, 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.