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FDA 510(k)

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

K-Number: K010652 · 2001-03-30

ApplicantSigma Diagnostics, Inc.
Decision Date2001-03-30
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K010652. 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 DIAGNOSTICS SIGMA-CAL, MODEL S2936?

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K010652.

When did SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 received FDA 510(k) clearance on 2001-03-30, under 510(k) number K010652.

Who is the listed applicant for SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936?

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

What is the FDA product code for SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936?

The FDA product code for SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 is JIX.

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Other records listing Sigma 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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