Cleared Traditional

ANTISERA TO HUMAN FERRITIN

K822472 · Kent Laboratories, Inc. · Microbiology
Sep 1982
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K822472 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FERRITIN, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 44 days after receiving the submission on August 17, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K822472 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1982
Decision Date September 30, 1982
Days to Decision 44 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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