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)

ONTRAK TESTCARD 9

K-Number: K050321 · 2005-04-18

ApplicantVarian, Inc.
Decision Date2005-04-18
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTCARD 9 is the device name listed in this FDA 510(k) record. The listed applicant is Varian, Inc.. It received FDA 510(k) clearance on 2005-04-18 under 510(k) number K050321. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTCARD 9?

ONTRAK TESTCARD 9 is a medical device that received FDA 510(k) clearance on 2005-04-18. The listed applicant is Varian, Inc.. The 510(k) number is K050321.

When did ONTRAK TESTCARD 9 receive FDA 510(k) clearance?

ONTRAK TESTCARD 9 received FDA 510(k) clearance on 2005-04-18, under 510(k) number K050321.

Who is the listed applicant for ONTRAK TESTCARD 9?

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

What is the FDA product code for ONTRAK TESTCARD 9?

The FDA product code for ONTRAK TESTCARD 9 is DIO.

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 Varian, 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.

K060896MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKITK051235ON TRAK TESTCARDK033902ONTRAK TESTCUP II AND ONSITE CUPKITK033659VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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.

↑