Cleared Traditional

K831194 - GLUCOKEY

K831194 is an FDA 510(k) clearance for GLUCOKEY, manufactured by Ulster Scientific, Inc.. The device is a Class 2 Hematology device with product code CGA cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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

FDA 510(k) Submission Details - K831194

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
Combination Product No
PCCP Authorized No
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.

CGA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 285
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K831194.
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983
ENZYMATIC GLUCOSE DETERMINATION
K832926 · Seragen Diagnostics, Inc. · Oct 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · Stanbio Laboratory · Aug 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983