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FDA 510(k)

CULTURE MEDIA FOR INSOLATION NEISSERIA

K-Number: K791398 · 1979-08-22

ApplicantIsle Media and Sterile Products, Inc.
Decision Date1979-08-22
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE MEDIA FOR INSOLATION NEISSERIA is the device name listed in this FDA 510(k) record. The listed applicant is Isle Media and Sterile Products, Inc.. It received FDA 510(k) clearance on 1979-08-22 under 510(k) number K791398. 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 INSOLATION NEISSERIA?

CULTURE MEDIA FOR INSOLATION NEISSERIA is a medical device that received FDA 510(k) clearance on 1979-08-22. The listed applicant is Isle Media and Sterile Products, Inc.. The 510(k) number is K791398.

When did CULTURE MEDIA FOR INSOLATION NEISSERIA receive FDA 510(k) clearance?

CULTURE MEDIA FOR INSOLATION NEISSERIA received FDA 510(k) clearance on 1979-08-22, under 510(k) number K791398.

Who is the listed applicant for CULTURE MEDIA FOR INSOLATION NEISSERIA?

The FDA 510(k) record lists Isle Media and Sterile Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CULTURE MEDIA FOR INSOLATION NEISSERIA?

The FDA product code for CULTURE MEDIA FOR INSOLATION NEISSERIA is JTY.

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Other records listing Isle Media and Sterile Products, 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.

K831671MODIFIED SOYBEAN CASEIN DIGEST BROTHK821218CAMPY-S AGARK820863MEDIA FOR IN-VITRO DIAGNOSTIC USEK812796ANAEROBIC CNA BLOOD AGARK812795ANAEROBIC BLOOD AGARK812798MOTILITY GI MEDIUM

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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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