Cleared Traditional

IMMUNO/SLE

K872910 · Immunostics Co., Inc. · Immunology
Aug 1987
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K872910 is an FDA 510(k) clearance for the IMMUNO/SLE, a System, Test, Systemic Lupus Erythematosus (Class II — Special Controls, product code DHC), submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on August 12, 1987, 19 days after receiving the submission on July 24, 1987. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5820.

Submission Details

510(k) Number K872910 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1987
Decision Date August 12, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHC — System, Test, Systemic Lupus Erythematosus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5820

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