Cleared Traditional

72 DETERMIN. SIZE RADIAL IMMUNOD. TEST

K811613 · Kent Laboratories, Inc. · Immunology
Aug 1981
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K811613 is an FDA 510(k) clearance for the 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981, 65 days after receiving the submission on June 8, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K811613 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1981
Decision Date August 12, 1981
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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