Cleared Traditional

BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT

K032240 · The Binding Site, Ltd. · Immunology
Sep 2003
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K032240 is an FDA 510(k) clearance for the BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 29, 2003, 70 days after receiving the submission on July 21, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K032240 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2003
Decision Date September 29, 2003
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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