Cleared Traditional

K831194 - GLUCOKEY (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831194 · Ulster Scientific, Inc. · Hematology device
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Oct 1983
Decision
202d
Days
Class 2
Risk

K831194 is an FDA 510(k) clearance for the GLUCOKEY. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Ulster Scientific, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 202 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1345 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ulster Scientific, Inc. devices

Submission Details

510(k) Number K831194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1983
Decision Date October 31, 1983
Days to Decision 202 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 113d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, 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 Hematology devices follow this clearance model.

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