SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY— 510(k) K980885

Name: FDA 510(k) clearance K980885
Creator: U.S. Food and Drug Administration
Published: 1998-08-21

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K980885 for SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY, Substantially Equivalent on 1998-08-21. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1998-03-09
Decision date: 1998-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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