Cleared Traditional

K830340 - FITKIT I CHECKUP KIT

K830340 is an FDA 510(k) clearance for FITKIT I CHECKUP KIT, manufactured by Boditestor. The device is a Class 1 Hematology device with product code CDM cleared through the Traditional 510(k) pathway after a 195-day FDA review.

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.

FDA 510(k) Submission Details - K830340

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 113d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

CDM Device Classification - Class 1, General Controls

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.

Regulatory Peers - CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

All 8
Devices cleared under the same product code (CDM) and FDA review panel - the closest regulatory comparables to K830340.
WAKO(TM) PRETEST 5A
K873366 · Wako Chemicals USA, Inc. · Jan 1988
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · Miles Laboratories, Inc. · Sep 1985
FITKIT I CHECKUP KIT
K821799 · Patton, Boggs & Blow · Aug 1983
DIA STRIPS SYSTEM
K831623 · California Immuno Diagnostic, Inc. · Jul 1983
REAGENT STRIPS FOR URINALYSIS
K790965 · Miles Laboratories, Inc. · Jun 1979
K830340 · FITKIT I CHECKUP KIT
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