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FDA 510(k)

SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM

K-Number: K960053 · 1996-06-28

ApplicantSelfcare, Inc.
Decision Date1996-06-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH 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 1996-06-28 under 510(k) number K960053. 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 SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM?

SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Selfcare, Inc.. The 510(k) number is K960053.

When did SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM receive FDA 510(k) clearance?

SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM received FDA 510(k) clearance on 1996-06-28, under 510(k) number K960053.

Who is the listed applicant for SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH 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 SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM?

The FDA product code for SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH 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 SYSTEMK000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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