RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E— 510(k) K000336

Name: FDA 510(k) clearance K000336
Creator: U.S. Food and Drug Administration
Published: 2000-06-09

Substantially Equivalent

Rhigene, Inc.

FDA 510(k) clearance K000336 for RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E, Substantially Equivalent on 2000-06-09. Applicant: Rhigene, Inc.. Device class: 2.

Clearance details

Applicant: Rhigene, Inc.
Product code: Code NBO
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2000-02-03
Decision date: 2000-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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