Cleared Special

CHEMSTRIP 101 URINE ANALYZER

K983510 · Boehringer Mannheim Corp. · Chemistry
Oct 1998
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K983510 is an FDA 510(k) clearance for the CHEMSTRIP 101 URINE ANALYZER, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on October 27, 1998, 20 days after receiving the submission on October 7, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K983510 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1998
Decision Date October 27, 1998
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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