ORIGEN ANALYZER— 510(k) K962166

Substantially Equivalent

Igen, Inc.

FDA 510(k) clearance K962166 for ORIGEN ANALYZER, Substantially Equivalent on 1996-07-31. Applicant: Igen, Inc..

Clearance details

Applicant: Igen, Inc.
Product code: Code JJQ
Advisory panel: Clinical Chemistry
Date received: 1996-06-04
Decision date: 1996-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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