Cleared Traditional

K830180 - REFEREE BRAND CO-OXIMETER REAGENTS

K830180 is the FDA 510(k) clearance for REFEREE BRAND CO-OXIMETER REAGENTS by Analytical Products, Inc.. It is a Class 2 Hematology device (product code KHG) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K830180 · Analytical Products, Inc. · Hematology device
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Apr 1983
Decision
80d
Days
Class 2
Risk

K830180 is an FDA 510(k) clearance for the REFEREE BRAND CO-OXIMETER REAGENTS. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Analytical Products, Inc. devices

Submission Details

510(k) Number K830180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date April 08, 1983
Days to Decision 80 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 113d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 Hematology devices follow this clearance model.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 17
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K830180.
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 1985
HEMOGLOBIN
K851432 · Pointe Scientific, Inc., · Jul 1985
CORNING 2500 CO-OXIMETER
K830590 · Corning Medical & Scientific · Apr 1983
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · Miles Laboratories, Inc. · Jul 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · Miles Laboratories, Inc. · Jul 1982