RHIGENE MESACUP2 TEST- RNP— 510(k) K000752

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K000752 for RHIGENE MESACUP2 TEST- RNP, Substantially Equivalent on 2000-05-09. Applicant: Rhigene, Inc.. Device class: 2.

Clearance details

Applicant
Rhigene, Inc.
Product code
Code LKO
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Des Plaines, IL, US
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