Cleared Traditional

MEDICA IIF-ANTI-THYROID ANTIBODY TEST

K843343 · Medical Diagnostics, Ca. · Immunology
Oct 1984
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K843343 is an FDA 510(k) clearance for the MEDICA IIF-ANTI-THYROID ANTIBODY TEST, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Medical Diagnostics, Ca. (Calsbad, US). The FDA issued a Cleared decision on October 22, 1984, 56 days after receiving the submission on August 27, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K843343 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1984
Decision Date October 22, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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