Cleared Traditional

DIASTAT ANTI-RO (SS-A)

K905194 · Shield Diagnostics, Ltd. · Immunology
Dec 1990
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K905194 is an FDA 510(k) clearance for the DIASTAT ANTI-RO (SS-A), a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Shield Diagnostics, Ltd. (Scotland, KN). The FDA issued a Cleared decision on December 13, 1990, 24 days after receiving the submission on November 19, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K905194 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1990
Decision Date December 13, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKO — Anti-rnp Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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