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FDA 510(k)

VIDAS D-DIMER (DD) ASSAY

K-Number: K973819 · 1998-03-10

ApplicantBiomerieux Vitek, Inc.
Decision Date1998-03-10
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VIDAS D-DIMER (DD) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K973819. 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 VIDAS D-DIMER (DD) ASSAY?

VIDAS D-DIMER (DD) ASSAY is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K973819.

When did VIDAS D-DIMER (DD) ASSAY receive FDA 510(k) clearance?

VIDAS D-DIMER (DD) ASSAY received FDA 510(k) clearance on 1998-03-10, under 510(k) number K973819.

Who is the listed applicant for VIDAS D-DIMER (DD) ASSAY?

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

What is the FDA product code for VIDAS D-DIMER (DD) ASSAY?

The FDA product code for VIDAS D-DIMER (DD) ASSAY is DAP.

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Other records listing Biomerieux Vitek, 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.

K972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARDK962549VIDAS CREATINE KINASE MB ASSAY 30-421

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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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