Cleared Traditional

ACCU-CHEK COMFORT CURVE TEST STRIPS

K980731 · Boehringer Mannheim Corp. · Chemistry
May 1998
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K980731 is an FDA 510(k) clearance for the ACCU-CHEK COMFORT CURVE TEST STRIPS, 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 May 22, 1998, 86 days after receiving the submission on February 25, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K980731 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1998
Decision Date May 22, 1998
Days to Decision 86 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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