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FDA 510(k)

CHOCOLATE AGAR GC BASE PLATE

K-Number: K840065 · 1984-02-13

ApplicantOtisville Biotech, Inc.
Decision Date1984-02-13
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHOCOLATE AGAR GC BASE PLATE 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 1984-02-13 under 510(k) number K840065. 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 CHOCOLATE AGAR GC BASE PLATE?

CHOCOLATE AGAR GC BASE PLATE is a medical device that received FDA 510(k) clearance on 1984-02-13. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K840065.

When did CHOCOLATE AGAR GC BASE PLATE receive FDA 510(k) clearance?

CHOCOLATE AGAR GC BASE PLATE received FDA 510(k) clearance on 1984-02-13, under 510(k) number K840065.

Who is the listed applicant for CHOCOLATE AGAR GC BASE PLATE?

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 CHOCOLATE AGAR GC BASE PLATE?

The FDA product code for CHOCOLATE AGAR GC BASE PLATE 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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