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FDA 510(k)

MDA D-DIMER

K-Number: K000492 · 2000-06-07

ApplicantOrganon Teknika Corp.
Decision Date2000-06-07
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDA D-DIMER is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 2000-06-07 under 510(k) number K000492. 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 MDA D-DIMER?

MDA D-DIMER is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Organon Teknika Corp.. The 510(k) number is K000492.

When did MDA D-DIMER receive FDA 510(k) clearance?

MDA D-DIMER received FDA 510(k) clearance on 2000-06-07, under 510(k) number K000492.

Who is the listed applicant for MDA D-DIMER?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDA D-DIMER?

The FDA product code for MDA D-DIMER is DAP.

Related Clinical Trials

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.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SNK993576BACT/ALERT MP PROCESS BOTTLE

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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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