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)

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

K-Number: K020226 · 2002-08-22

ApplicantHellen Professional Services
Decision Date2002-08-22
Product CodeJWZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 is the device name listed in this FDA 510(k) record. The listed applicant is Hellen Professional Services. It received FDA 510(k) clearance on 2002-08-22 under 510(k) number K020226. The device is classified under product code JWZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03?

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 is a medical device that received FDA 510(k) clearance on 2002-08-22. The listed applicant is Hellen Professional Services. The 510(k) number is K020226.

When did XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 receive FDA 510(k) clearance?

XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 received FDA 510(k) clearance on 2002-08-22, under 510(k) number K020226.

Who is the listed applicant for XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03?

The FDA 510(k) record lists Hellen Professional Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03?

The FDA product code for XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 is JWZ.

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 Hellen Professional Services 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.

K981536QUANTECH MYOGLOBIN ASSAY

Related Devices (Code: JWZ)

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.

K033864GENZYME OSOM TRICHOMONAS RAPID TESTGenzyme Corp.K020595XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01Xenotope Diagnostics, Inc.K894246MERIVIEW TM TRICHOMONASMeridian Diagnostics, Inc.K892802SUPER DUOMercia Diagnostics , Ltd.K892263MERIFLUOR(TM) -TRICHOMONASMeridian Diagnostics, Inc.K875138TRICHOMATE(R) SUPERMercia Diagnostics , Ltd.

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.

↑