Cleared Traditional

ACCU-CHEK HQ SYSTEM

K983047 · Boehringer Mannheim Corp. · Chemistry
Feb 1999
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K983047 is an FDA 510(k) clearance for the ACCU-CHEK HQ SYSTEM, 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 February 5, 1999, 157 days after receiving the submission on September 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K983047 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1998
Decision Date February 05, 1999
Days to Decision 157 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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