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FDA 510(k)

GLUCOSE-TRINDER-ADDAY KIT

K-Number: K842506 · 1984-07-19

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-07-19
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE-TRINDER-ADDAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-07-19 under 510(k) number K842506. 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-TRINDER-ADDAY KIT?

GLUCOSE-TRINDER-ADDAY KIT is a medical device that received FDA 510(k) clearance on 1984-07-19. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K842506.

When did GLUCOSE-TRINDER-ADDAY KIT receive FDA 510(k) clearance?

GLUCOSE-TRINDER-ADDAY KIT received FDA 510(k) clearance on 1984-07-19, under 510(k) number K842506.

Who is the listed applicant for GLUCOSE-TRINDER-ADDAY KIT?

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

What is the FDA product code for GLUCOSE-TRINDER-ADDAY KIT?

The FDA product code for GLUCOSE-TRINDER-ADDAY KIT is CGA.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

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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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