Cleared Traditional

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

K980885 · Shield Diagnostics, Ltd. · Hematology
Aug 1998
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K980885 is an FDA 510(k) clearance for the SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on August 21, 1998, 165 days after receiving the submission on March 9, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K980885 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1998
Decision Date August 21, 1998
Days to Decision 165 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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