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)

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

K-Number: K871105 · 1987-05-13

ApplicantNew Horizons Diagnostics Co.
Decision Date1987-05-13
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE is the device name listed in this FDA 510(k) record. The listed applicant is New Horizons Diagnostics Co.. It received FDA 510(k) clearance on 1987-05-13 under 510(k) number K871105. The device is classified under product code LIC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE?

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE is a medical device that received FDA 510(k) clearance on 1987-05-13. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K871105.

When did THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE receive FDA 510(k) clearance?

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE received FDA 510(k) clearance on 1987-05-13, under 510(k) number K871105.

Who is the listed applicant for THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE?

The FDA 510(k) record lists New Horizons Diagnostics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE?

The FDA product code for THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE is LIC.

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 New Horizons Diagnostics Co. 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.

K932622CHOLERA SMART(TM)K925190PYLORISCREENK922432CHOLERASCREENK874761RAPID COLORIMETRIC DIRECT STREP A TESTK871226SYPHILIS SEROLOGICAL REAGENTSK862195RAPID BACTERIURIA SCREEN (RBS)

View all 10 devices →

Related Devices (Code: LIC)

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.

K921075PHADEBACT MONOCLONAL GC TEST, MODIFICATIONKaro Bio Diagnostics ABK911430IDEIA(TM) CHLAMYDIA, MODIFICATIONNovo Nordisk Diagnostics, Ltd.K880076G-MARKBainbridge Laboratories, Inc.K874078MERITEC(TM)-GCMeridian Diagnostics, Inc.K851650PHADEBACT MONOCLONAL GC OMNI TESTPharmacia, Inc.K850351PHADEBACT MONOCLONAL GC TESTPharmacia, 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.

↑