Cleared Traditional

DIASTAT ANTI-PR3 (C-ANCA) KIT

K942813 · Shield Diagnostics, Ltd. · Immunology
Mar 1995
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K942813 is an FDA 510(k) clearance for the DIASTAT ANTI-PR3 (C-ANCA) KIT, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on March 6, 1995, 265 days after receiving the submission on June 14, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K942813 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1994
Decision Date March 06, 1995
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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