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FDA 510(k)

SIGMA WASH CONCENTRATE SOLUTION

K-Number: K933703 · 1993-12-10

ApplicantSigma Chemical Co.
Decision Date1993-12-10
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA WASH CONCENTRATE SOLUTION 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 1993-12-10 under 510(k) number K933703. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA WASH CONCENTRATE SOLUTION?

SIGMA WASH CONCENTRATE SOLUTION is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Sigma Chemical Co.. The 510(k) number is K933703.

When did SIGMA WASH CONCENTRATE SOLUTION receive FDA 510(k) clearance?

SIGMA WASH CONCENTRATE SOLUTION received FDA 510(k) clearance on 1993-12-10, under 510(k) number K933703.

Who is the listed applicant for SIGMA WASH CONCENTRATE SOLUTION?

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 SIGMA WASH CONCENTRATE SOLUTION?

The FDA product code for SIGMA WASH CONCENTRATE SOLUTION is JJE.

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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 REAGENTK933692SIGMA CO2 ACID REAGENT

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Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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