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)

OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K-Number: K964493 · 1997-02-06

ApplicantUnipath , Ltd.
Decision Date1997-02-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K964493. 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 OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Unipath , Ltd.. The 510(k) number is K964493.

When did OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC receive FDA 510(k) clearance?

OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC received FDA 510(k) clearance on 1997-02-06, under 510(k) number K964493.

Who is the listed applicant for OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

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

What is the FDA product code for OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC?

The FDA product code for OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC 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 Unipath , Ltd. 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK042280FACT PLUS ONE-STEP PREGNANCY TEST KITK041404CLEARBLUE EASY EASY READ PREGNANCY TEST

View all 73 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.

↑