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)

CHOLERA SMART(TM)

K-Number: K932622 · 1995-06-27

ApplicantNew Horizons Diagnostics Co.
Decision Date1995-06-27
Product CodeGSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHOLERA SMART(TM) 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 1995-06-27 under 510(k) number K932622. The device is classified under product code GSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLERA SMART(TM)?

CHOLERA SMART(TM) is a medical device that received FDA 510(k) clearance on 1995-06-27. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K932622.

When did CHOLERA SMART(TM) receive FDA 510(k) clearance?

CHOLERA SMART(TM) received FDA 510(k) clearance on 1995-06-27, under 510(k) number K932622.

Who is the listed applicant for CHOLERA SMART(TM)?

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 CHOLERA SMART(TM)?

The FDA product code for CHOLERA SMART(TM) is GSQ.

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.

K925190PYLORISCREENK922432CHOLERASCREENK874761RAPID COLORIMETRIC DIRECT STREP A TESTK871226SYPHILIS SEROLOGICAL REAGENTSK871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAEK862195RAPID BACTERIURIA SCREEN (RBS)

View all 10 devices →

Related Devices (Code: GSQ)

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.

K954995QUIX RAPID CHOLERA STRIP TESTGuardian Scientific, Corp.K922432CHOLERASCREENNew Horizons Diagnostics Co.

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.

↑