Cleared Traditional

FITKIT I CHECKUP KIT (K830340) - FDA 510(k) Clearance

Class I Hematology device.

K830340 · Boditestor · Hematology device
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Aug 1983
Decision
195d
Days
Class 1
Risk

K830340 is an FDA 510(k) clearance for the FITKIT I CHECKUP KIT. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by Boditestor (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 195 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1785 - 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.

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Submission Details

510(k) Number K830340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1983
Decision Date August 16, 1983
Days to Decision 195 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 113d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
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.