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FDA 510(k)

DEXPAD, BLOOD GLUCOSE STRIP

K-Number: K880585 · 1988-04-18

ApplicantMach Diag. C/O Wichita State University
Decision Date1988-04-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEXPAD, BLOOD GLUCOSE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Mach Diag. C/O Wichita State University. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880585. 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 DEXPAD, BLOOD GLUCOSE STRIP?

DEXPAD, BLOOD GLUCOSE STRIP is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Mach Diag. C/O Wichita State University. The 510(k) number is K880585.

When did DEXPAD, BLOOD GLUCOSE STRIP receive FDA 510(k) clearance?

DEXPAD, BLOOD GLUCOSE STRIP received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880585.

Who is the listed applicant for DEXPAD, BLOOD GLUCOSE STRIP?

The FDA 510(k) record lists Mach Diag. C/O Wichita State University as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXPAD, BLOOD GLUCOSE STRIP?

The FDA product code for DEXPAD, BLOOD GLUCOSE STRIP is CGA.

Related Clinical Trials

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.

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Other records listing Mach Diag. C/O Wichita State University 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.

K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C

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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