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FDA 510(k)

SERUM POTASSIUM REAGENT SET

K-Number: K861713 · 1986-05-23

ApplicantSterling Diagnostics, Inc.
Decision Date1986-05-23
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM POTASSIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861713. 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 SERUM POTASSIUM REAGENT SET?

SERUM POTASSIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K861713.

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

SERUM POTASSIUM REAGENT SET received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861713.

Who is the listed applicant for SERUM POTASSIUM REAGENT SET?

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

What is the FDA product code for SERUM POTASSIUM REAGENT SET?

The FDA product code for SERUM POTASSIUM REAGENT SET is CEJ.

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Other records listing Sterling 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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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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