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FDA 510(k)

POTASSIUM TEST KIT

K-Number: K832553 · 1983-09-20

ApplicantMallinckrodt Critical Care
Decision Date1983-09-20
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832553. 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 KIT?

POTASSIUM TEST KIT is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K832553.

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

POTASSIUM TEST KIT received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832553.

Who is the listed applicant for POTASSIUM TEST KIT?

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

What is the FDA product code for POTASSIUM TEST KIT?

The FDA product code for POTASSIUM TEST KIT is CEJ.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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