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FDA 510(k)

NEISSERIA GONORRHOEAE TEST

K-Number: K820007 · 1982-01-29

ApplicantNew Horizons Diagnostics Co.
Decision Date1982-01-29
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEISSERIA GONORRHOEAE TEST 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 1982-01-29 under 510(k) number K820007. 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 NEISSERIA GONORRHOEAE TEST?

NEISSERIA GONORRHOEAE TEST is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is New Horizons Diagnostics Co.. The 510(k) number is K820007.

When did NEISSERIA GONORRHOEAE TEST receive FDA 510(k) clearance?

NEISSERIA GONORRHOEAE TEST received FDA 510(k) clearance on 1982-01-29, under 510(k) number K820007.

Who is the listed applicant for NEISSERIA GONORRHOEAE TEST?

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 NEISSERIA GONORRHOEAE TEST?

The FDA product code for NEISSERIA GONORRHOEAE TEST is LIC.

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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)K925190PYLORISCREENK922432CHOLERASCREENK874761RAPID COLORIMETRIC DIRECT STREP A TESTK871226SYPHILIS SEROLOGICAL REAGENTSK871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

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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.

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