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FDA 510(k)

GLUCOMETER DEX DIABETES CARE SYSTEM

K-Number: K963500 · 1997-01-21

ApplicantBayer Corp.
Decision Date1997-01-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER DEX DIABETES CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1997-01-21 under 510(k) number K963500. 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 GLUCOMETER DEX DIABETES CARE SYSTEM?

GLUCOMETER DEX DIABETES CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-21. The listed applicant is Bayer Corp.. The 510(k) number is K963500.

When did GLUCOMETER DEX DIABETES CARE SYSTEM receive FDA 510(k) clearance?

GLUCOMETER DEX DIABETES CARE SYSTEM received FDA 510(k) clearance on 1997-01-21, under 510(k) number K963500.

Who is the listed applicant for GLUCOMETER DEX DIABETES CARE SYSTEM?

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

What is the FDA product code for GLUCOMETER DEX DIABETES CARE SYSTEM?

The FDA product code for GLUCOMETER DEX DIABETES CARE SYSTEM is CGA.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 devices →

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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