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FDA 510(k)

CHOLERASCREEN

K-Number: K922432 · 1992-12-07

ApplicantNew Horizons Diagnostics Co.
Decision Date1992-12-07
Product CodeGSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHOLERASCREEN 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 1992-12-07 under 510(k) number K922432. 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 CHOLERASCREEN?

CHOLERASCREEN is a medical device that received FDA 510(k) clearance on 1992-12-07. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K922432.

When did CHOLERASCREEN receive FDA 510(k) clearance?

CHOLERASCREEN received FDA 510(k) clearance on 1992-12-07, under 510(k) number K922432.

Who is the listed applicant for CHOLERASCREEN?

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 CHOLERASCREEN?

The FDA product code for CHOLERASCREEN is GSQ.

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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)K925190PYLORISCREENK874761RAPID COLORIMETRIC DIRECT STREP A TESTK871226SYPHILIS SEROLOGICAL REAGENTSK871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAEK862195RAPID BACTERIURIA SCREEN (RBS)

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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.K932622CHOLERA SMART(TM)New 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.

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