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FDA 510(k)

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

K-Number: K003329 · 2001-03-01

ApplicantSigma Diagnostics, Inc.
Decision Date2001-03-01
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 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 2001-03-01 under 510(k) number K003329. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217?

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K003329.

When did SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 receive FDA 510(k) clearance?

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 received FDA 510(k) clearance on 2001-03-01, under 510(k) number K003329.

Who is the listed applicant for SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217?

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 DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217?

The FDA product code for SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 is GGC.

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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: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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