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FDA 510(k)

GLUCOSE OXIDASE REAGENT SET

K-Number: K855194 · 1986-01-14

ApplicantTechnostics Intl.
Decision Date1986-01-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Technostics Intl.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K855194. 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 OXIDASE REAGENT SET?

GLUCOSE OXIDASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Technostics Intl.. The 510(k) number is K855194.

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

GLUCOSE OXIDASE REAGENT SET received FDA 510(k) clearance on 1986-01-14, under 510(k) number K855194.

Who is the listed applicant for GLUCOSE OXIDASE REAGENT SET?

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

What is the FDA product code for GLUCOSE OXIDASE REAGENT SET?

The FDA product code for GLUCOSE OXIDASE REAGENT SET is CGA.

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Other records listing Technostics Intl. 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.

K855188CPK (UV) REAGENT KITK860111URIC ACID REAGENT SETK855190MAGNESIUM REAGENT SETK860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SETK860109ENZYMATIC UREA NITROGEN REAGENT SETK860112TOTAL LIPIDS REAGENT SET

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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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