Cleared Traditional

K851467 - HEMOGLOBIN ANALYZER

K851467 is an FDA 510(k) clearance for HEMOGLOBIN ANALYZER, manufactured by Awareness Technology, Inc.. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K851467 · Awareness Technology, Inc. · Hematology device
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Jul 1985
Decision
92d
Days
Class 2
Risk

K851467 is an FDA 510(k) clearance for the HEMOGLOBIN ANALYZER. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 92 days - within the typical 510(k) review window.

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

View all Awareness Technology, Inc. devices

FDA 510(k) Submission Details - K851467

510(k) Number K851467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date July 16, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHG Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K851467.
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986
HEMOGLOBIN REAGENT SET
K860475 · Sterling Diagnostics, Inc. · Mar 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 1985
HEMOGLOBIN
K851432 · Pointe Scientific, Inc., · Jul 1985
EASYTOUCH HEMOGLOBIN REAGENT
K832750 · Worthington Diagnostic Systems · Sep 1983
REFEREE BRAND CO-OXIMETER REAGENTS
K830180 · Analytical Products, Inc. · Apr 1983