Cleared Traditional

K810665 - GILUCOCHEK REFLECTANCE METER

K810665 is the FDA 510(k) clearance for GILUCOCHEK REFLECTANCE METER by Lifescan, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K810665 · Lifescan, Inc. · Chemistry device
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Apr 1981
Decision
37d
Days
Class 1
Risk

K810665 is an FDA 510(k) clearance for the GILUCOCHEK REFLECTANCE METER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Lifescan, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Lifescan, Inc. devices

Submission Details

510(k) Number K810665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1981
Decision Date April 17, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 93
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K810665.
VERSACHEM ANALYZER
K821561 · Emd Chemicals, Inc. · Jun 1982
PHADEZYM ANALYZER
K813563 · Pharmacia, Inc. · Mar 1982
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · Abbott Laboratories · Nov 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · Beckman Instruments, Inc. · Mar 1981
DRUG DETECTION SYSTEM
K802619 · Syva Co. · Oct 1980
AGA UV PHOTOMETER
K801499 · Syva Co. · Aug 1980