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FDA 510(k)

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001

K-Number: K000582 · 2000-12-05

ApplicantAbbott Diabetes Care, Inc.
Decision Date2000-12-05
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 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 2000-12-05 under 510(k) number K000582. 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 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001?

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K000582.

When did FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 receive FDA 510(k) clearance?

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 received FDA 510(k) clearance on 2000-12-05, under 510(k) number K000582.

Who is the listed applicant for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001?

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 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001?

The FDA product code for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001 is LFR.

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Other records listing Abbott Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemK223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemK213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemK212132FreeStyle Libre 3 Continuous Glucose Monitoring System

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Related Devices (Code: LFR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

Official Source

View on FDA Database →

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

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