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FDA 510(k)

BCS POTASSIUM TURBIDIMETRIC TEST

K-Number: K850258 · 1985-02-07

ApplicantBioclinical Systems, Inc.
Decision Date1985-02-07
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BCS POTASSIUM TURBIDIMETRIC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K850258. 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 BCS POTASSIUM TURBIDIMETRIC TEST?

BCS POTASSIUM TURBIDIMETRIC TEST is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K850258.

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

BCS POTASSIUM TURBIDIMETRIC TEST received FDA 510(k) clearance on 1985-02-07, under 510(k) number K850258.

Who is the listed applicant for BCS POTASSIUM TURBIDIMETRIC TEST?

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

What is the FDA product code for BCS POTASSIUM TURBIDIMETRIC TEST?

The FDA product code for BCS POTASSIUM TURBIDIMETRIC TEST is CEJ.

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Other records listing Bioclinical Systems, Inc. as applicant

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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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