Cleared Traditional

K823060 - HEMOGLOBIN REAGENT

K823060 is the FDA 510(k) clearance for HEMOGLOBIN REAGENT by Biorent Diagnostic, Inc.. It is a Class 2 Chemistry device (product code KHG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823060 · Biorent Diagnostic, Inc. · Chemistry device
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Nov 1982
Decision
35d
Days
Class 2
Risk

K823060 is an FDA 510(k) clearance for the HEMOGLOBIN REAGENT. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Biorent Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7500 - the FDA in vitro diagnostics and chemistry 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 Biorent Diagnostic, Inc. devices

Submission Details

510(k) Number K823060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date November 22, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 21
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K823060.
HEMOGLOBIN
K851432 · Pointe Scientific, Inc., · Jul 1985
REFEREE BRAND CO-OXIMETER REAGENTS
K830180 · Analytical Products, Inc. · Apr 1983
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
CYANMETHEMOGLOBIN TEST
K820596 · Boehringer Mannheim Corp. · Mar 1982