FDA 510(k)

THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS

K-Number: K070984 · 2007-11-01

Decision Date2007-11-01

Product CodeLFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2007-11-01 under 510(k) number K070984. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS?

THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS is a medical device that received FDA 510(k) clearance on 2007-11-01. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K070984.

When did THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS receive FDA 510(k) clearance?

THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS received FDA 510(k) clearance on 2007-11-01, under 510(k) number K070984.

Who is the listed applicant for THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS?

The FDA product code for THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS is LFR.

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Related Devices (Code: LFR)

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical Corporation K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical Corporation K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.