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FDA 510(k)

NYC-GC MEDIA

K-Number: K832948 · 1983-09-29

ApplicantOtisville Biotech, Inc.
Decision Date1983-09-29
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NYC-GC MEDIA is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832948. 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 NYC-GC MEDIA?

NYC-GC MEDIA is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K832948.

When did NYC-GC MEDIA receive FDA 510(k) clearance?

NYC-GC MEDIA received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832948.

Who is the listed applicant for NYC-GC MEDIA?

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

What is the FDA product code for NYC-GC MEDIA?

The FDA product code for NYC-GC MEDIA is JTY.

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Other records listing Otisville Biotech, 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.

K862397BIOTIS DECARBOXYLASE MEDIA, LYSINEK862393BIOTIS LITMUS MILKK862398BIOTIS DECARBOXYLASE MEDIA, ORNITHINEK862390BIOTIS BORDET GENGOU AGARK862388BIOTIS TCBS AGARK862392BIOTIS MOTILITY TEST 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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