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FDA 510(k)

CULTURE MEDIA/ISOLA. PATHO. NEISSERIA

K-Number: K780022 · 1978-01-20

ApplicantDiagnostic Culture System
Decision Date1978-01-20
Product CodeJTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CULTURE MEDIA/ISOLA. PATHO. NEISSERIA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Culture System. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780022. 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/ISOLA. PATHO. NEISSERIA?

CULTURE MEDIA/ISOLA. PATHO. NEISSERIA is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Diagnostic Culture System. The 510(k) number is K780022.

When did CULTURE MEDIA/ISOLA. PATHO. NEISSERIA receive FDA 510(k) clearance?

CULTURE MEDIA/ISOLA. PATHO. NEISSERIA received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780022.

Who is the listed applicant for CULTURE MEDIA/ISOLA. PATHO. NEISSERIA?

The FDA 510(k) record lists Diagnostic Culture System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CULTURE MEDIA/ISOLA. PATHO. NEISSERIA?

The FDA product code for CULTURE MEDIA/ISOLA. PATHO. NEISSERIA is JTY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Culture System 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.

K780021URINE SCREENING KITS

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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