Cleared Traditional

HYTEC AUTOIMMUNE KIT (JO-1)

K954895 · Hycor Biomedical, Inc. · Immunology
Mar 1996
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K954895 is an FDA 510(k) clearance for the HYTEC AUTOIMMUNE KIT (JO-1), a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 20, 1996, 147 days after receiving the submission on October 25, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K954895 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1995
Decision Date March 20, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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