Cleared Traditional

K833318 - NORMAL GOAT SERUM

K833318 is an FDA 510(k) clearance for NORMAL GOAT SERUM, manufactured by Biosan Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K833318

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
6d faster than avg
Panel avg: 105d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

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 24
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
CEA CONTROL PLASMA
K812658 · Pacific Hemostasis · Sep 1981
THREE LEVEL CONTROL SERA
K810459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981