Cleared Traditional

K833318 - NORMAL GOAT SERUM

K833318 is the FDA 510(k) clearance for NORMAL GOAT SERUM by Biosan Laboratories, Inc.. It is a Class 2 Immunology device (product code DHX) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

K833318 is an FDA 510(k) clearance for the NORMAL GOAT SERUM. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Biosan Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosan Laboratories, Inc. devices

Submission Details

510(k) Number K833318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1983
Decision Date January 03, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 104d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHX System, Test, Carcinoembryonic Antigen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHX System, Test, Carcinoembryonic Antigen

All 19
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K833318.
IMMULITE CEA
K970877 · Diagnostic Products Corp. · Sep 1997
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · Tosoh Medics, Inc. · Mar 1993
TRI-LEVEL LIGAND CONTROL
K864877 · Ciba Corning Diagnostics Corp. · May 1987
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · Ventrex Laboratories, Inc. · Apr 1982
THREE LEVEL CONTROL SERA
K810459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981