Cleared Traditional

CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT

K913668 · The Binding Site, Ltd. · Immunology
Dec 1991
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K913668 is an FDA 510(k) clearance for the CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 20, 1991, 123 days after receiving the submission on August 19, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number K913668 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1991
Decision Date December 20, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDB — Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5210

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