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FDA 510(k)

TECHNICON RA-100 SYSTEM POTASSIUM

K-Number: K883586 · 1988-11-29

ApplicantTechnicon Instruments Corp.
Decision Date1988-11-29
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA-100 SYSTEM POTASSIUM is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K883586. 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 TECHNICON RA-100 SYSTEM POTASSIUM?

TECHNICON RA-100 SYSTEM POTASSIUM is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K883586.

When did TECHNICON RA-100 SYSTEM POTASSIUM receive FDA 510(k) clearance?

TECHNICON RA-100 SYSTEM POTASSIUM received FDA 510(k) clearance on 1988-11-29, under 510(k) number K883586.

Who is the listed applicant for TECHNICON RA-100 SYSTEM POTASSIUM?

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

What is the FDA product code for TECHNICON RA-100 SYSTEM POTASSIUM?

The FDA product code for TECHNICON RA-100 SYSTEM POTASSIUM is CEJ.

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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.K883585TECHNICON ASSIST POTASSIUMTechnicon Instruments Corp.K881440IQ POTASSIUMBd Becton Dickinson Vacutainer Systems Preanalytic

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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