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)

IMPROVED GONO GEN

K-Number: K821362 · 1982-08-04

ApplicantNew Horizons Diagnostics Co.
Decision Date1982-08-04
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMPROVED GONO GEN 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 1982-08-04 under 510(k) number K821362. 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 IMPROVED GONO GEN?

IMPROVED GONO GEN is a medical device that received FDA 510(k) clearance on 1982-08-04. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K821362.

When did IMPROVED GONO GEN receive FDA 510(k) clearance?

IMPROVED GONO GEN received FDA 510(k) clearance on 1982-08-04, under 510(k) number K821362.

Who is the listed applicant for IMPROVED GONO GEN?

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 IMPROVED GONO GEN?

The FDA product code for IMPROVED GONO GEN 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 REAGENTSK871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

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.K871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAENew Horizons Diagnostics Co.K851650PHADEBACT MONOCLONAL GC OMNI 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.

↑