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)

HARDYDISK BACITRACIN, 10MCG, MODEL Z927

K-Number: K011086 · 2001-04-26

ApplicantHardy Diagnostics
Decision Date2001-04-26
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HARDYDISK BACITRACIN, 10MCG, MODEL Z927 is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2001-04-26 under 510(k) number K011086. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARDYDISK BACITRACIN, 10MCG, MODEL Z927?

HARDYDISK BACITRACIN, 10MCG, MODEL Z927 is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Hardy Diagnostics. The 510(k) number is K011086.

When did HARDYDISK BACITRACIN, 10MCG, MODEL Z927 receive FDA 510(k) clearance?

HARDYDISK BACITRACIN, 10MCG, MODEL Z927 received FDA 510(k) clearance on 2001-04-26, under 510(k) number K011086.

Who is the listed applicant for HARDYDISK BACITRACIN, 10MCG, MODEL Z927?

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 HARDYDISK BACITRACIN, 10MCG, MODEL Z927?

The FDA product code for HARDYDISK BACITRACIN, 10MCG, MODEL Z927 is JTN.

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: JTN)

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)Hardy DiagnosticsK261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics

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.

↑