Cleared Traditional

FERRITIN RIA KIT

K791860 · Cis Radiopharmaceuticals, Inc. · Immunology
Dec 1979
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K791860 is an FDA 510(k) clearance for the FERRITIN RIA KIT, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 78 days after receiving the submission on September 19, 1979. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K791860 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1979
Decision Date December 06, 1979
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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