Cleared Traditional

ACCU-CHECK VOICEMATE

K982079 · Boehringer Mannheim Corp. · Chemistry
Aug 1998
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K982079 is an FDA 510(k) clearance for the ACCU-CHECK VOICEMATE, a Glucose Dehydrogenase, Glucose (Class II — Special Controls, product code LFR), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on August 28, 1998, 74 days after receiving the submission on June 15, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K982079 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1998
Decision Date August 28, 1998
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFR — Glucose Dehydrogenase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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