Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

K-Number: K032017 · 2003-08-08

ApplicantBio-Rad
Decision Date2003-08-08
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K032017. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3?

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Bio-Rad. The 510(k) number is K032017.

When did LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 receive FDA 510(k) clearance?

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 received FDA 510(k) clearance on 2003-08-08, under 510(k) number K032017.

Who is the listed applicant for LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3?

The FDA product code for LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 is GGN.

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 Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

View all 319 devices →

Related Devices (Code: GGN)

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.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc.

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.

↑