Cleared Traditional

TWIN BUN/GLUCOSE

K861775 · Boehringer Mannheim Corp. · Chemistry
Jun 1986
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K861775 is an FDA 510(k) clearance for the TWIN BUN/GLUCOSE, a Diacetyl-monoxime, Urea Nitrogen (Class II — Special Controls, product code CDW), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on June 27, 1986, 50 days after receiving the submission on May 8, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K861775 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1986
Decision Date June 27, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDW — Diacetyl-monoxime, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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