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FDA 510(k)

NEISSERIA GONORRHOEAE FLUORO-KIT

K-Number: K800328 · 1980-03-03

ApplicantClinical Sciences, Inc.
Decision Date1980-03-03
Product CodeGTH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEISSERIA GONORRHOEAE FLUORO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K800328. The device is classified under product code GTH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEISSERIA GONORRHOEAE FLUORO-KIT?

NEISSERIA GONORRHOEAE FLUORO-KIT is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K800328.

When did NEISSERIA GONORRHOEAE FLUORO-KIT receive FDA 510(k) clearance?

NEISSERIA GONORRHOEAE FLUORO-KIT received FDA 510(k) clearance on 1980-03-03, under 510(k) number K800328.

Who is the listed applicant for NEISSERIA GONORRHOEAE FLUORO-KIT?

The FDA 510(k) record lists Clinical Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEISSERIA GONORRHOEAE FLUORO-KIT?

The FDA product code for NEISSERIA GONORRHOEAE FLUORO-KIT is GTH.

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Related Devices (Code: GTH)

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.

K900546BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENTBaxter Healthcare CorpK861835MICROTRAK NEISERRIA GONORRHOEAE CULTURE TESTSyva 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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