Cleared Traditional

K821462 - ULTRACHEM T-BILI, #64971

K821462 is an FDA 510(k) clearance for ULTRACHEM T-BILI, manufactured by Emd Chemicals, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821462 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
14d
Days
Class 2
Risk

K821462 is an FDA 510(k) clearance for the ULTRACHEM T-BILI, #64971. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1982 after a review of 14 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 Emd Chemicals, Inc. devices

FDA 510(k) Submission Details - K821462

510(k) Number K821462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 01, 1982
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

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 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K821462.
TOTAL BILIRUBIN REAGENT
K830714 · Hi Chem, Inc. · Apr 1983
ULTRACHEM T-BILI
K821873 · Harleco Diagnostics · Jul 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · Omega Medical Electronics · Jul 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · The Dow Chemical Co. · Apr 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · The Dow Chemical Co. · Apr 1982
TOTAL & DIRECT BILIRUBIN REAGENT SET
K812841 · Anco Medical Reagents & Assoc. · Nov 1981