Cleared Traditional

K791760 - GLUCOSE HEXOKINASE COIL REAGENT SYSTEM

K791760 is the FDA 510(k) clearance for GLUCOSE HEXOKINASE COIL REAGENT SYSTEM by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791760 · Fisher Scientific Co., LLC · Chemistry device
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Sep 1979
Decision
22d
Days
Class 2
Risk

K791760 is an FDA 510(k) clearance for the GLUCOSE HEXOKINASE COIL REAGENT SYSTEM. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979 after a review of 22 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K791760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1979
Decision Date September 27, 1979
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K791760.
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · Reagents Applications, Inc. · Sep 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · Data Medical Associates, Inc. · May 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · Data Medical Associates, Inc. · May 1980
GLUCOSE (HK) REAGENT
K790786 · Gilford Diagnostics · Jun 1979
GLUCOSE REAGENT SYSTEM
K782136 · American Monitor Corp. · Jan 1979
GLUCOSE HEXOKINASE, AUTO K
K781723 · Medical Analysis Systems, Inc. · Nov 1978