Cleared Traditional

RADIAL IMMUNO-TEST FOR HUMAN FACTOR B

K831959 · Kent Laboratories, Inc. · Chemistry
Jul 1983
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K831959 is an FDA 510(k) clearance for the RADIAL IMMUNO-TEST FOR HUMAN FACTOR B, a Factor B, Antigen, Antiserum, Control (Class II — Special Controls, product code JZH), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 32 days after receiving the submission on June 17, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5320.

Submission Details

510(k) Number K831959 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1983
Decision Date July 19, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JZH — Factor B, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5320

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