FDA 510(k)

CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI

K-Number: K850732 · 1985-03-20

ApplicantRoseville Medical Laboratoriesu

Decision Date1985-03-20

Product CodeJTY

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI is the device name listed in this FDA 510(k) record. The listed applicant is Roseville Medical Laboratoriesu. It received FDA 510(k) clearance on 1985-03-20 under 510(k) number K850732. 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 MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI?

CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Roseville Medical Laboratoriesu. The 510(k) number is K850732.

When did CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI receive FDA 510(k) clearance?

CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850732.

Who is the listed applicant for CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI?

The FDA 510(k) record lists Roseville Medical Laboratoriesu as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI?

The FDA product code for CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI is JTY.

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Other records listing Roseville Medical Laboratoriesu as applicant

K850733MULTIPURPOSE CULTURE MEDIUM K850736SELECTIVE CULTURE MEDIUM K850734DIFFERENTIAL CULTURE MEDIUM K850737TRANSPORT CULTURE MEDIUM K850738SUPPLEMENT FOR CULTURE MEDIUM K850731CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING

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Related Devices (Code: JTY)

K210511InTray GCBiomed Diagnostics Incorporated K993033INTRAY 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.