AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA— 510(k) K030397

Substantially Equivalent

Hycor Biomedical , Ltd.

FDA 510(k) clearance K030397 for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA, Substantially Equivalent on 2003-03-21. Applicant: Hycor Biomedical , Ltd..

Clearance details

Applicant: Hycor Biomedical , Ltd.
Product code: Code MSV
Advisory panel: Immunology
Date received: 2003-02-06
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Penicuik, Midlothian, GB

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