Cleared Traditional

K830569 - CYNOX I HEMOGLOBINOMETER

K830569 is the FDA 510(k) clearance for CYNOX I HEMOGLOBINOMETER by Buffalo Medical Specialties Mfg., Inc.. It is a Class 1 Hematology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K830569 · Buffalo Medical Specialties Mfg., Inc. · Hematology device
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Apr 1983
Decision
45d
Days
Class 1
Risk

K830569 is an FDA 510(k) clearance for the CYNOX I HEMOGLOBINOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Buffalo Medical Specialties Mfg., Inc. (Walker, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2300 - 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 Buffalo Medical Specialties Mfg., Inc. devices

Submission Details

510(k) Number K830569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1983
Decision Date April 08, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
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