Cleared Traditional

C4 MININEPH ANTISERUM

K981785 · The Binding Site, Ltd. · Immunology
Dec 1999
Decision
579d
Days
Class 2
Risk

About This 510(k) Submission

K981785 is an FDA 510(k) clearance for the C4 MININEPH ANTISERUM, a Complement C4, Antigen, Antiserum, Control (Class II — Special Controls, product code DBI), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on December 20, 1999, 579 days after receiving the submission on May 20, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K981785 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1998
Decision Date December 20, 1999
Days to Decision 579 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DBI — Complement C4, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240