Cleared Traditional

MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

K011663 · The Binding Site, Ltd. · Immunology
Jul 2001
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K011663 is an FDA 510(k) clearance for the MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on July 30, 2001, 62 days after receiving the submission on May 29, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K011663 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2001
Decision Date July 30, 2001
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130

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