Cleared Traditional

DISTAT ANTI-DSDNA KIT

K905386 · Shield Diagnostics, Ltd. · Immunology
Dec 1990
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K905386 is an FDA 510(k) clearance for the DISTAT ANTI-DSDNA KIT, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on December 13, 1990, 13 days after receiving the submission on November 30, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K905386 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1990
Decision Date December 13, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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