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FDA 510(k)

QUANTAI UG REAGENT STRIP

K-Number: K893661 · 1989-11-08

ApplicantQuantai Biotronics, Inc.
Decision Date1989-11-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTAI UG REAGENT STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Quantai Biotronics, Inc.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K893661. 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 QUANTAI UG REAGENT STRIP?

QUANTAI UG REAGENT STRIP is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Quantai Biotronics, Inc.. The 510(k) number is K893661.

When did QUANTAI UG REAGENT STRIP receive FDA 510(k) clearance?

QUANTAI UG REAGENT STRIP received FDA 510(k) clearance on 1989-11-08, under 510(k) number K893661.

Who is the listed applicant for QUANTAI UG REAGENT STRIP?

The FDA 510(k) record lists Quantai Biotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTAI UG REAGENT STRIP?

The FDA product code for QUANTAI UG REAGENT STRIP is CGA.

Related Clinical Trials

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Other records listing Quantai Biotronics, Inc. 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.

K903191QUICK CHECK 3 FILMK880703QUANTAI BG(TM) REAGENT STRIP

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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