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FDA 510(k)

CULTURE TEST FOR NEISSERIA GONORRHOEAE

K-Number: K771035 · 1977-07-05

ApplicantMiles Laboratories, Inc.
Decision Date1977-07-05
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE TEST FOR NEISSERIA GONORRHOEAE is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-07-05 under 510(k) number K771035. The device is classified under product code JTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CULTURE TEST FOR NEISSERIA GONORRHOEAE?

CULTURE TEST FOR NEISSERIA GONORRHOEAE is a medical device that received FDA 510(k) clearance on 1977-07-05. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K771035.

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

CULTURE TEST FOR NEISSERIA GONORRHOEAE received FDA 510(k) clearance on 1977-07-05, under 510(k) number K771035.

Who is the listed applicant for CULTURE TEST FOR NEISSERIA GONORRHOEAE?

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

What is the FDA product code for CULTURE TEST FOR NEISSERIA GONORRHOEAE?

The FDA product code for CULTURE TEST FOR NEISSERIA GONORRHOEAE is JTY.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: JTY)

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.

K210511InTray GCBiomed Diagnostics IncorporatedK993033INTRAY GCBiomed Diagnostics, Inc.K954986GC BASE W/ 1% GCHIRemel, L.P.K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIABioclinical Systems, Inc.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, 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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