Cleared Traditional

IMX FERRITIN

K881345 · Abbott Laboratories · Immunology
May 1988
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K881345 is an FDA 510(k) clearance for the IMX FERRITIN, a Igg, Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DGD), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 11, 1988, 42 days after receiving the submission on March 30, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K881345 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1988
Decision Date May 11, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DGD — Igg, Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510