Cleared Traditional

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

K981883 · Boehringer Mannheim Corp. · Chemistry
Jul 1998
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K981883 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on July 7, 1998, 39 days after receiving the submission on May 29, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K981883 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1998
Decision Date July 07, 1998
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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