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FDA 510(k)

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2

K-Number: K933693 · 1993-10-13

ApplicantSigma Chemical Co.
Decision Date1993-10-13
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 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 1993-10-13 under 510(k) number K933693. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA CX-3 CALIBRATION STANDARD LEVEL 2?

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 is a medical device that received FDA 510(k) clearance on 1993-10-13. The listed applicant is Sigma Chemical Co.. The 510(k) number is K933693.

When did SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 receive FDA 510(k) clearance?

SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 received FDA 510(k) clearance on 1993-10-13, under 510(k) number K933693.

Who is the listed applicant for SIGMA CX-3 CALIBRATION STANDARD LEVEL 2?

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 CX-3 CALIBRATION STANDARD LEVEL 2?

The FDA product code for SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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