Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BHI W/VANCOMYCIN AGAR

K-Number: K964560 · 1997-01-15

ApplicantHardy Diagnostics
Decision Date1997-01-15
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BHI W/VANCOMYCIN AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 1997-01-15 under 510(k) number K964560. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BHI W/VANCOMYCIN AGAR?

BHI W/VANCOMYCIN AGAR is a medical device that received FDA 510(k) clearance on 1997-01-15. The listed applicant is Hardy Diagnostics. The 510(k) number is K964560.

When did BHI W/VANCOMYCIN AGAR receive FDA 510(k) clearance?

BHI W/VANCOMYCIN AGAR received FDA 510(k) clearance on 1997-01-15, under 510(k) number K964560.

Who is the listed applicant for BHI W/VANCOMYCIN AGAR?

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

What is the FDA product code for BHI W/VANCOMYCIN AGAR?

The FDA product code for BHI W/VANCOMYCIN AGAR is JSO.

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 Hardy Diagnostics 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.

K262113HardyDisk AST Tebipenem 10µg (TBP10)K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534Viral Transport Medium

View all 108 devices →

Related Devices (Code: JSO)

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.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, 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.

↑