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FDA 510(k)

DETERMINATION OF MAGNESIUM IN SERUM OR

K-Number: K841259 · 1984-05-07

ApplicantSigma Chemical Co.
Decision Date1984-05-07
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DETERMINATION OF MAGNESIUM IN SERUM OR is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K841259. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETERMINATION OF MAGNESIUM IN SERUM OR?

DETERMINATION OF MAGNESIUM IN SERUM OR is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Sigma Chemical Co.. The 510(k) number is K841259.

When did DETERMINATION OF MAGNESIUM IN SERUM OR receive FDA 510(k) clearance?

DETERMINATION OF MAGNESIUM IN SERUM OR received FDA 510(k) clearance on 1984-05-07, under 510(k) number K841259.

Who is the listed applicant for DETERMINATION OF MAGNESIUM IN SERUM OR?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DETERMINATION OF MAGNESIUM IN SERUM OR?

The FDA product code for DETERMINATION OF MAGNESIUM IN SERUM OR is JGJ.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: JGJ)

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.

K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.K122302ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLCK111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.

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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