FDA 510(k)

POTASSIUM REAGENT SET

K-Number: K813608 · 1982-01-22

Decision Date1982-01-22

Product CodeCEJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

POTASSIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813608. The device is classified under product code CEJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM REAGENT SET?

POTASSIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Diagnostic Specialties. The 510(k) number is K813608.

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

POTASSIUM REAGENT SET received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813608.

Who is the listed applicant for POTASSIUM REAGENT SET?

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

What is the FDA product code for POTASSIUM REAGENT SET?

The FDA product code for POTASSIUM REAGENT SET is CEJ.

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Other records listing Diagnostic Specialties as applicant

K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT K930823PROTEIN-BOUND GLUCOSE ASSAYN KIT K922032ENZIP URINARY MICROALBUMIN TEST K831180PREGNA-CERT, SLIDE PREGNANCY TEST K823109GENERIC PREGNANCY TEST

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Related Devices (Code: CEJ)

K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2Randox Laboratories, Ltd.K943026POTASSIUM QVETPrisma Systems K904033REFLOTRON POTASSIUM TEST TABSBoehringer Mannheim Corp.K902574POTASSIUM REAGENT SETTech-Co, Inc.K883586TECHNICON RA-100 SYSTEM POTASSIUMTechnicon Instruments Corp.K883585TECHNICON ASSIST POTASSIUMTechnicon Instruments Corp.

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.