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FDA 510(k)

UNI-CHECK REAGENT STRIP

K-Number: K924398 · 1992-12-23

ApplicantDiagnostic Solutions, Inc.
Decision Date1992-12-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNI-CHECK REAGENT STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K924398. 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 UNI-CHECK REAGENT STRIP?

UNI-CHECK REAGENT STRIP is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K924398.

When did UNI-CHECK REAGENT STRIP receive FDA 510(k) clearance?

UNI-CHECK REAGENT STRIP received FDA 510(k) clearance on 1992-12-23, under 510(k) number K924398.

Who is the listed applicant for UNI-CHECK REAGENT STRIP?

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

What is the FDA product code for UNI-CHECK REAGENT STRIP?

The FDA product code for UNI-CHECK REAGENT STRIP is CGA.

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Other records listing Diagnostic Solutions, 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.

K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENASK800675REAGENTS FOR DETERM. TOTAL BILIRUBIN

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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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