Cleared Traditional

K841648 - DIAGEM DIGITAL BLOOD GLUCOSE MONITOR

K841648 is the FDA 510(k) clearance for DIAGEM DIGITAL BLOOD GLUCOSE MONITOR by Forward Medical Supplies. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K841648 · Forward Medical Supplies · Chemistry device
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Oct 1984
Decision
174d
Days
Class 1
Risk

K841648 is an FDA 510(k) clearance for the DIAGEM DIGITAL BLOOD GLUCOSE MONITOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Forward Medical Supplies (Camillus, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 174 days - an extended review 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: 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.

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Submission Details

510(k) Number K841648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1984
Decision Date October 11, 1984
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
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 135
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