Cleared Traditional

NORMAL GOAT SERUM

K833318 · Biosan Laboratories, Inc. · Immunology
Jan 1984
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K833318 is an FDA 510(k) clearance for the NORMAL GOAT SERUM, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Biosan Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1984, 99 days after receiving the submission on September 26, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K833318 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1983
Decision Date January 03, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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