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FDA 510(k)

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K000583 · 2000-03-17

ApplicantSelfcare, Inc.
Decision Date2000-03-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 2000-03-17 under 510(k) number K000583. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-17. The listed applicant is Selfcare, Inc.. The 510(k) number is K000583.

When did FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2000-03-17, under 510(k) number K000583.

Who is the listed applicant for FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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Other records listing Selfcare, 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.

K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTK002134ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMK002049INVERNESS MEDICAL EARLY PREGNANCY TESTK001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

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Related Devices (Code: CGA)

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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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