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FDA 510(k)

POTASSIUM TEST

K-Number: K811661 · 1981-06-25

ApplicantKing Diagnostics, Inc.
Decision Date1981-06-25
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-06-25 under 510(k) number K811661. 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 TEST?

POTASSIUM TEST is a medical device that received FDA 510(k) clearance on 1981-06-25. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K811661.

When did POTASSIUM TEST receive FDA 510(k) clearance?

POTASSIUM TEST received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811661.

Who is the listed applicant for POTASSIUM TEST?

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

What is the FDA product code for POTASSIUM TEST?

The FDA product code for POTASSIUM TEST is CEJ.

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Other records listing King Diagnostics, 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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Related Devices (Code: CEJ)

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.

K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2Randox Laboratories, Ltd.K943026POTASSIUM QVETPrisma SystemsK904033REFLOTRON 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.

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