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FDA 510(k)

GLUCOSE DIAGNOSTIC REAGENT

K-Number: K801897 · 1980-10-10

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1980-10-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE DIAGNOSTIC REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Connecticut Diagnostics, Ltd.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K801897. 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 DIAGNOSTIC REAGENT?

GLUCOSE DIAGNOSTIC REAGENT is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K801897.

When did GLUCOSE DIAGNOSTIC REAGENT receive FDA 510(k) clearance?

GLUCOSE DIAGNOSTIC REAGENT received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801897.

Who is the listed applicant for GLUCOSE DIAGNOSTIC REAGENT?

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

What is the FDA product code for GLUCOSE DIAGNOSTIC REAGENT?

The FDA product code for GLUCOSE DIAGNOSTIC REAGENT is CGA.

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Other records listing Connecticut Diagnostics, Ltd. 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.

K905617VISI-STAPHK822501CDL ISOTONIC DILUENTK822500CDL LYSING REAGENTK822504CDL AUTO-LYSING REAGENTK811222INORGANIC PHOSPHORUS REAGENTSK801898URIC ACID DIAGNOSTIC 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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