Cleared Traditional

K830569 - CYNOX I HEMOGLOBINOMETER

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

K830569 · Buffalo Medical Specialties Mfg., Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K830569

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.

JJQ Device Classification - Class 1, General Controls

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 166
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K830569.
PHOTON IMMUNOASSAY ANALYZER
K832364 · Hybritech, Inc. · Aug 1983
SPECTROPHOTOMETER #390
K832206 · Abbott Diagnostics · Aug 1983
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC
K831866 · Varian Assoc., Inc. · Jul 1983
MANUALISA MICROTITRATION PLATE READER
K823590 · Ortho Diagnostic Systems, Inc. · Feb 1983
COLORIMETERS SERIES ONE 12
K830101 · Innotron of Oregon, Inc. · Jan 1983
SPECTROPHOTOMETER
K823720 · Macomb Chemical Co. · Jan 1983