Cleared Traditional

K811202 - ULTRACHEM GLUC-DH, ITEM NO. 65048

K811202 is an FDA 510(k) clearance for ULTRACHEM GLUC-DH, manufactured by Harleco. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K811202 · Harleco · Chemistry device
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May 1981
Decision
26d
Days
Class 2
Risk

K811202 is an FDA 510(k) clearance for the ULTRACHEM GLUC-DH, ITEM NO. 65048. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 26 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 devices

FDA 510(k) Submission Details - K811202

510(k) Number K811202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date May 27, 1981
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K811202.
ULTRACHEM GLUC-DH, #65048
K821469 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM GLUC-DH
K813427 · Harleco · Dec 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
K813042 · Harleco · Nov 1981
GLUCOSE (GDH) REAGENT
K791213 · Gilford Diagnostics · Aug 1979
KINETIC DETERMINATION OF UV GLUCOSE
K791110 · The Dow Chemical Co. · Aug 1979
BLOOD SUGAR
K781783 · Gilford Diagnostics · Dec 1978