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FDA 510(k)

GLUCOSE TEST SYSTEM

K-Number: K923587 · 1992-12-28

ApplicantPolymer Technology Corp.
Decision Date1992-12-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Corp.. It received FDA 510(k) clearance on 1992-12-28 under 510(k) number K923587. 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 GLUCOSE TEST SYSTEM?

GLUCOSE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-28. The listed applicant is Polymer Technology Corp.. The 510(k) number is K923587.

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

GLUCOSE TEST SYSTEM received FDA 510(k) clearance on 1992-12-28, under 510(k) number K923587.

Who is the listed applicant for GLUCOSE TEST SYSTEM?

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

What is the FDA product code for GLUCOSE TEST SYSTEM?

The FDA product code for GLUCOSE TEST SYSTEM is CGA.

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Other records listing Polymer Technology 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.

K011945RIGID GAS PERMEABLE CONTACT LENS SOLUTIONK980133BAUSCH & LOMB WETTING AND SOAKING SOLUTIONK974466BOSTON ADVANCE CLEANERK973217BOSTON LIQUID ENZYMATIC CLEANERK970698BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENSK951552BOSTON CONTACT LENS CASE

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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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