Cleared Traditional

MPO ELISA TEST SYSTEM

K961765 · Immunoprobe, Inc. · Immunology
Aug 1996
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K961765 is an FDA 510(k) clearance for the MPO ELISA TEST SYSTEM, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Immunoprobe, Inc. (Frederick, US). The FDA issued a Cleared decision on August 19, 1996, 104 days after receiving the submission on May 7, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K961765 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1996
Decision Date August 19, 1996
Days to Decision 104 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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