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)

IMUBIND TPA ELISA, MODEL 860

K-Number: K013492 · 2002-03-13

ApplicantAmerican Diagnostica, Inc.
Decision Date2002-03-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMUBIND TPA ELISA, MODEL 860 is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 2002-03-13 under 510(k) number K013492. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMUBIND TPA ELISA, MODEL 860?

IMUBIND TPA ELISA, MODEL 860 is a medical device that received FDA 510(k) clearance on 2002-03-13. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K013492.

When did IMUBIND TPA ELISA, MODEL 860 receive FDA 510(k) clearance?

IMUBIND TPA ELISA, MODEL 860 received FDA 510(k) clearance on 2002-03-13, under 510(k) number K013492.

Who is the listed applicant for IMUBIND TPA ELISA, MODEL 860?

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

What is the FDA product code for IMUBIND TPA ELISA, MODEL 860?

The FDA product code for IMUBIND TPA ELISA, MODEL 860 is GGP.

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 American Diagnostica, 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.

K080069DIMERTESTK063323SPECTROLYSE PAI-1, MODEL 101201K052124ACTICLOT, MODEL 824K013637ACTICHROME HEPARIN (ANTI-FIIA)K013318ACTICHROME HEPARIN (ANTI-FXA), MODEL 832K013168IMUBIND PLASMA PAI-1 ELISA,MODEL 822

View all 10 devices →

Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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.

↑