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FDA 510(k)

RELIEF PLUS ONE REAGENT STRIP MODIFICATION

K-Number: K934892 · 1994-01-11

ApplicantDiagnostic Solutions, Inc.
Decision Date1994-01-11
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RELIEF PLUS ONE REAGENT STRIP MODIFICATION 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 1994-01-11 under 510(k) number K934892. 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 RELIEF PLUS ONE REAGENT STRIP MODIFICATION?

RELIEF PLUS ONE REAGENT STRIP MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-01-11. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K934892.

When did RELIEF PLUS ONE REAGENT STRIP MODIFICATION receive FDA 510(k) clearance?

RELIEF PLUS ONE REAGENT STRIP MODIFICATION received FDA 510(k) clearance on 1994-01-11, under 510(k) number K934892.

Who is the listed applicant for RELIEF PLUS ONE REAGENT STRIP MODIFICATION?

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 RELIEF PLUS ONE REAGENT STRIP MODIFICATION?

The FDA product code for RELIEF PLUS ONE REAGENT STRIP MODIFICATION is CGA.

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Other records listing Diagnostic Solutions, Inc. as applicant

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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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