Cleared Traditional

TOTAL HAEMOLYTIC COMPLEMENT RID KIT

K992488 · The Binding Site, Ltd. · Immunology
Sep 1999
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K992488 is an FDA 510(k) clearance for the TOTAL HAEMOLYTIC COMPLEMENT RID KIT, a Complement C9, Antigen, Antiserum, Control (Class II — Special Controls, product code DAE), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 17, 1999, 53 days after receiving the submission on July 26, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K992488 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1999
Decision Date September 17, 1999
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAE — Complement C9, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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