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FDA 510(k)

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

K-Number: K950196 · 1995-06-30

ApplicantBioclinical Systems, Inc.
Decision Date1995-06-30
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1995-06-30 under 510(k) number K950196. 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 MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA?

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K950196.

When did CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA receive FDA 510(k) clearance?

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA received FDA 510(k) clearance on 1995-06-30, under 510(k) number K950196.

Who is the listed applicant for CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA?

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

What is the FDA product code for CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA?

The FDA product code for CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA is JTY.

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Other records listing Bioclinical Systems, Inc. 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.

K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSK933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARK933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARK873086ROUND 1K860334VISI-CHECK HLH TEST MONOCLONALK860333MICRO-ELISA HLH TEST KIT MONOCLONAL

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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.K933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARBioclinical Systems, Inc.K933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARBioclinical Systems, Inc.K934331THAYER MARTIN, MODIFIED PILL POCKETHardy Diagnostics

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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