ANTI-RNP AND ANTI-SM ANTIBODY TEST— 510(k) K895338

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K895338 for ANTI-RNP AND ANTI-SM ANTIBODY TEST, Substantially Equivalent on 1989-10-17. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LKO
Advisory panel: Immunology
Date received: 1989-08-31
Decision date: 1989-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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