Cleared Traditional

K831902 - FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
(FDA 510(k) Clearance)

K831902 · Dako Corp. · Immunology
Jul 1983
Decision
34d
Days
Class 2
Risk

K831902 is an FDA 510(k) clearance for the FLUORESCEIN CONJUGATED IMMUNOGLOBIN-, a Albumin, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code DDZ), submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 34 days after receiving the submission on June 14, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K831902 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date July 18, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDZ — Albumin, Fitc, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040