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FDA 510(k)

EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM

K-Number: K961337 · 1996-06-21

ApplicantMedisense, Inc.
Decision Date1996-06-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medisense, Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961337. 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 EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM?

EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Medisense, Inc.. The 510(k) number is K961337.

When did EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM receive FDA 510(k) clearance?

EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961337.

Who is the listed applicant for EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM?

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

What is the FDA product code for EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM?

The FDA product code for EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM is CGA.

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Other records listing Medisense, 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.

K983504PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST STK982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST STK983253PRECISION A1C HOME HBA1C SAMPLE COLLECTION KITK971812PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIPK963676PRECISION G BLOOD GLUCOSE TESTING SYSTEMK962295PRECISION QID BLOOD GLUCOSE TEST STRIP

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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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