Cleared Traditional

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

K803272 · Icl Scientific · Immunology
Jan 1981
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K803272 is an FDA 510(k) clearance for the AUTOMATED IMMUNOPRECIPITIN METHOD/ICG, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on January 26, 1981, 28 days after receiving the submission on December 29, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K803272 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1980
Decision Date January 26, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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