Cleared Traditional

FITKIT I CHECKUP KIT

K821799 · Patton, Boggs & Blow · Chemistry
Aug 1983
Decision
424d
Days
Class 1
Risk

About This 510(k) Submission

K821799 is an FDA 510(k) clearance for the FITKIT I CHECKUP KIT, a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I — General Controls, product code CDM), submitted by Patton, Boggs & Blow (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983, 424 days after receiving the submission on June 18, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1785.

Submission Details

510(k) Number K821799 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1982
Decision Date August 16, 1983
Days to Decision 424 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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