Cleared Traditional

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB

K012292 · The Binding Site, Ltd. · Immunology
Aug 2001
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K012292 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on August 31, 2001, 42 days after receiving the submission on July 20, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K012292 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2001
Decision Date August 31, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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