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FDA 510(k)

MINIQUANT D-DIMER, MODEL 1447

K-Number: K002642 · 2001-02-05

ApplicantBiopool Intl., Inc.
Decision Date2001-02-05
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MINIQUANT D-DIMER, MODEL 1447 is the device name listed in this FDA 510(k) record. The listed applicant is Biopool Intl., Inc.. It received FDA 510(k) clearance on 2001-02-05 under 510(k) number K002642. 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 MINIQUANT D-DIMER, MODEL 1447?

MINIQUANT D-DIMER, MODEL 1447 is a medical device that received FDA 510(k) clearance on 2001-02-05. The listed applicant is Biopool Intl., Inc.. The 510(k) number is K002642.

When did MINIQUANT D-DIMER, MODEL 1447 receive FDA 510(k) clearance?

MINIQUANT D-DIMER, MODEL 1447 received FDA 510(k) clearance on 2001-02-05, under 510(k) number K002642.

Who is the listed applicant for MINIQUANT D-DIMER, MODEL 1447?

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

What is the FDA product code for MINIQUANT D-DIMER, MODEL 1447?

The FDA product code for MINIQUANT D-DIMER, MODEL 1447 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biopool Intl., 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.

K983898BIOCLOT APC SENSITIVITYK981752I-STAT COAGULATION CONTROL SETK980314FETAL D TECTION KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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