Cleared Traditional

K771102 - UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS

K771102 is an FDA 510(k) clearance for UV GLUCOSE DETERM., manufactured by The Dow Chemical Co.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K771102 · The Dow Chemical Co. · Chemistry device
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Nov 1977
Decision
155d
Days
Class 2
Risk

K771102 is an FDA 510(k) clearance for the UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K771102

510(k) Number K771102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1977
Decision Date November 22, 1977
Days to Decision 155 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
67d slower than avg
Panel avg: 88d · This submission: 155d
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.