Cleared Traditional

SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT

K002561 · The Binding Site, Ltd. · Immunology
Oct 2000
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K002561 is an FDA 510(k) clearance for the SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT, a Igd, Antigen, Antiserum, Control (Class II — Special Controls, product code CZJ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on October 26, 2000, 70 days after receiving the submission on August 17, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K002561 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2000
Decision Date October 26, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CZJ — Igd, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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