Cleared Traditional

K821867 - ULTRACHEM GLUC-DH

K821867 is the FDA 510(k) clearance for ULTRACHEM GLUC-DH by Harleco Diagnostics. It is a Class 2 Chemistry device (product code LFR) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K821867 · Harleco Diagnostics · Chemistry device
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Jul 1982
Decision
11d
Days
Class 2
Risk

K821867 is an FDA 510(k) clearance for the ULTRACHEM GLUC-DH. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 K821867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1982
Decision Date July 06, 1982
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFR Glucose Dehydrogenase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - LFR Glucose Dehydrogenase, Glucose

All 48
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K821867.
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · Em Diagnostic Systems, Inc. · Dec 1987
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726 · Trace Scientific , Ltd. · Apr 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · Em Diagnostic Systems, Inc. · Feb 1986
ULTRACHEM GLUC-DH, #65048
K821463 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM GLUC-DH, #65048
K821469 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM GLUC-DH
K813427 · Harleco · Dec 1981