Cleared Traditional

K821873 - ULTRACHEM T-BILI

K821873 is the FDA 510(k) clearance for ULTRACHEM T-BILI by Harleco Diagnostics. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K821873 · Harleco Diagnostics · Chemistry device
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Jul 1982
Decision
19d
Days
Class 2
Risk

K821873 is an FDA 510(k) clearance for the ULTRACHEM T-BILI. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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

Submission Details

510(k) Number K821873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1982
Decision Date July 14, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 172
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K821873.
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · Gilford Diagnostics · Jul 1983
DIRECT BILIRUBIN REAGENT
K831844 · Gilford Diagnostics · Jul 1983
TOTAL BILIRUBIN REAGENT
K830714 · Hi Chem, Inc. · Apr 1983
ULTRACHEM T-BILI, #64971
K821462 · Emd Chemicals, Inc. · Jun 1982
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · Beckman Instruments, Inc. · Oct 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · Beckman Instruments, Inc. · Oct 1981