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FDA 510(k)

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

K-Number: K003267 · 2001-03-15

ApplicantSigma Diagnostics, Inc.
Decision Date2001-03-15
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A 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 2001-03-15 under 510(k) number K003267. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A?

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K003267.

When did SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A received FDA 510(k) clearance on 2001-03-15, under 510(k) number K003267.

Who is the listed applicant for SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A?

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 AUTO D-DIMER, MODEL CRS126-A?

The FDA product code for SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A is DAP.

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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: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare 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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