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FDA 510(k)

VISUAL BLOOD GLUCOSE TEST SYSTEM

K-Number: K884993 · 1988-12-29

ApplicantDiagnostic Systems
Decision Date1988-12-29
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISUAL BLOOD GLUCOSE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1988-12-29 under 510(k) number K884993. 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 VISUAL BLOOD GLUCOSE TEST SYSTEM?

VISUAL BLOOD GLUCOSE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Diagnostic Systems. The 510(k) number is K884993.

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

VISUAL BLOOD GLUCOSE TEST SYSTEM received FDA 510(k) clearance on 1988-12-29, under 510(k) number K884993.

Who is the listed applicant for VISUAL BLOOD GLUCOSE TEST SYSTEM?

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

What is the FDA product code for VISUAL BLOOD GLUCOSE TEST SYSTEM?

The FDA product code for VISUAL BLOOD GLUCOSE TEST SYSTEM is CGA.

Related Clinical Trials

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Other records listing Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893966HDL PRECIPITATING REAGENTK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641K880787EASY-TEST LACTIC ACID (LA)

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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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