Cleared Traditional

K822323 - ULTRACHEM BUN-UV, 65080 & 65081

K822323 is an FDA 510(k) clearance for ULTRACHEM BUN-UV, manufactured by Harleco Diagnostics. The device is a Class 2 Chemistry device with product code CDW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K822323 · Harleco Diagnostics · Chemistry device
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Sep 1982
Decision
30d
Days
Class 2
Risk

K822323 is an FDA 510(k) clearance for the ULTRACHEM BUN-UV, 65080 & 65081. Classified as Diacetyl-monoxime, Urea Nitrogen (product code CDW), Class II - Special Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on September 2, 1982 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Harleco Diagnostics devices

FDA 510(k) Submission Details - K822323

510(k) Number K822323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date September 02, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDW Device Classification - Class 2, Special Controls

Product Code CDW Diacetyl-monoxime, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDW Diacetyl-monoxime, Urea Nitrogen

All 14
Devices cleared under the same product code (CDW) and FDA review panel - the closest regulatory comparables to K822323.
TWIN BUN/GLUCOSE
K861775 · Boehringer Mannheim Corp. · Jun 1986
UREA NITROGEN REAGENT SET
K860419 · Sterling Diagnostics, Inc. · Feb 1986
UREA NITROGEN REAGENT SET
K841068 · Medical Specialties, Inc. · May 1984
UREA NITROGEN REAGENT SET
K821212 · Omega Medical Electronics · Jul 1982
UREA NITROGEN REAGENT SET
K813415 · Anco Medical Reagents & Assoc. · Dec 1981
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
K800673 · Diagnostic Solutions, Inc. · May 1980