ANTI-ENA ANTIBODY TEST KIT— 510(k) K920386

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K920386 for ANTI-ENA ANTIBODY TEST KIT, Substantially Equivalent on 1992-03-30. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1992-01-30
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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