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FDA 510(k)

REAGENT SYSTEM, INORGANIC PHOSPHORUS

K-Number: K781806 · 1979-01-17

ApplicantSigma Chemical Co.
Decision Date1979-01-17
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SYSTEM, INORGANIC PHOSPHORUS 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 1979-01-17 under 510(k) number K781806. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SYSTEM, INORGANIC PHOSPHORUS?

REAGENT SYSTEM, INORGANIC PHOSPHORUS is a medical device that received FDA 510(k) clearance on 1979-01-17. The listed applicant is Sigma Chemical Co.. The 510(k) number is K781806.

When did REAGENT SYSTEM, INORGANIC PHOSPHORUS receive FDA 510(k) clearance?

REAGENT SYSTEM, INORGANIC PHOSPHORUS received FDA 510(k) clearance on 1979-01-17, under 510(k) number K781806.

Who is the listed applicant for REAGENT SYSTEM, INORGANIC PHOSPHORUS?

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 REAGENT SYSTEM, INORGANIC PHOSPHORUS?

The FDA product code for REAGENT SYSTEM, INORGANIC PHOSPHORUS is CEO.

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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: CEO)

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K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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