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FDA 510(k)

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

K-Number: K013545 · 2001-11-15

ApplicantSigma Diagnostics, Inc.
Decision Date2001-11-15
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 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 2001-11-15 under 510(k) number K013545. 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 CONTROL, LEVEL 3, MODEL A8221?

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 is a medical device that received FDA 510(k) clearance on 2001-11-15. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K013545.

When did SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 received FDA 510(k) clearance on 2001-11-15, under 510(k) number K013545.

Who is the listed applicant for SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221?

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 CONTROL, LEVEL 3, MODEL A8221?

The FDA product code for SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 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 A8096K012410INFINITY HBA KIT, MODELS 537-A, 537-BK010652SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

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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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