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FDA 510(k)

GLUCOSITE TEST SYSTEM

K-Number: K971145 · 1997-09-17

ApplicantGds Technology, LLC
Decision Date1997-09-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSITE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology, LLC. It received FDA 510(k) clearance on 1997-09-17 under 510(k) number K971145. 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 GLUCOSITE TEST SYSTEM?

GLUCOSITE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Gds Technology, LLC. The 510(k) number is K971145.

When did GLUCOSITE TEST SYSTEM receive FDA 510(k) clearance?

GLUCOSITE TEST SYSTEM received FDA 510(k) clearance on 1997-09-17, under 510(k) number K971145.

Who is the listed applicant for GLUCOSITE TEST SYSTEM?

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

What is the FDA product code for GLUCOSITE TEST SYSTEM?

The FDA product code for GLUCOSITE TEST SYSTEM is CGA.

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Other records listing Gds Technology, LLC 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.

K994073HEMOSITE TEST SYSTEMK992132CHOLESITE TEST SYSTEMK973649HEMOSITE TEST SYSTEMK911801KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CONK882038GDS ENZYMATIC SALICYLATE REAGENTK880829GDS ENZYMATIC ACETAMINOPHEN REAGENT

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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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