Cleared Traditional

K951750 - GLUCOSE TEST ITEM NUMBER 97375/94

K951750 is an FDA 510(k) clearance for GLUCOSE TEST ITEM NUMBER 97375/94, manufactured by Emd Chemicals, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K951750 · Emd Chemicals, Inc. · Chemistry device
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Sep 1995
Decision
142d
Days
Class 2
Risk

K951750 is an FDA 510(k) clearance for the GLUCOSE TEST ITEM NUMBER 97375/94. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 6, 1995 after a review of 142 days - within the typical 510(k) review window.

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.

View all Emd Chemicals, Inc. devices

FDA 510(k) Submission Details - K951750

510(k) Number K951750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date September 06, 1995
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 K951750.
HEMOCUE B-GLCOSE SYSTEM
K962415 · Hemocue, Inc. · Oct 1996
HEMOCUE B-GLUCOSE SYSTEM
K961311 · Hemocue, Inc. · Aug 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833 · Boehringer Mannheim Corp. · Feb 1996
ADVANTAGE TEST STRIPS
K951887 · Boehringer Mannheim Corp. · Aug 1995
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