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)

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

K-Number: K061413 · 2006-10-13

ApplicantGen-Probe, Inc.
Decision Date2006-10-13
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K061413. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM?

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K061413.

When did APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM receive FDA 510(k) clearance?

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM received FDA 510(k) clearance on 2006-10-13, under 510(k) number K061413.

Who is the listed applicant for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM?

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

What is the FDA product code for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM?

The FDA product code for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM is MKZ.

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 Gen-Probe, 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.

K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERK111409APTIMA COMBO 2 ASSAYK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061509TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

View all 62 devices →

Related Devices (Code: MKZ)

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.

K230451Aptima® Chlamydia trachomatis AssayHologic, Inc.K110923COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.K091724BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & COK090824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & COK081824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & COK080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITAbbott Molecular, 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.

↑