DISTAT ANTI-SCL-70 KIT— 510(k) K912291

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K912291 for DISTAT ANTI-SCL-70 KIT, Substantially Equivalent on 1991-07-30. Applicant: Shield Diagnostics, Ltd..

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code LKJ
Advisory panel: Immunology
Date received: 1991-05-23
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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