Cleared Traditional

FIAX C4 ASSAY

K772114 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology
Nov 1977
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K772114 is an FDA 510(k) clearance for the FIAX C4 ASSAY, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Idt, A Division of Whittaker M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977, 23 days after receiving the submission on November 7, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K772114 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1977
Decision Date November 30, 1977
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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