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FDA 510(k)

DMA GLUCOSE (OXIDASE) PROCEDURE

K-Number: K943241 · 1994-10-20

ApplicantData Medical Associates, Inc.
Decision Date1994-10-20
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DMA GLUCOSE (OXIDASE) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1994-10-20 under 510(k) number K943241. 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 DMA GLUCOSE (OXIDASE) PROCEDURE?

DMA GLUCOSE (OXIDASE) PROCEDURE is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K943241.

When did DMA GLUCOSE (OXIDASE) PROCEDURE receive FDA 510(k) clearance?

DMA GLUCOSE (OXIDASE) PROCEDURE received FDA 510(k) clearance on 1994-10-20, under 510(k) number K943241.

Who is the listed applicant for DMA GLUCOSE (OXIDASE) PROCEDURE?

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

What is the FDA product code for DMA GLUCOSE (OXIDASE) PROCEDURE?

The FDA product code for DMA GLUCOSE (OXIDASE) PROCEDURE is CGA.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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