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)

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN

K-Number: K983310 · 1998-12-17

ApplicantAccumed Intl., Inc.
Decision Date1998-12-17
Product CodeJTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1998-12-17 under 510(k) number K983310. The device is classified under product code JTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN?

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN is a medical device that received FDA 510(k) clearance on 1998-12-17. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K983310.

When did SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN receive FDA 510(k) clearance?

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN received FDA 510(k) clearance on 1998-12-17, under 510(k) number K983310.

Who is the listed applicant for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN?

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

What is the FDA product code for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN?

The FDA product code for SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN is JTT.

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 Accumed Intl., 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.

K984489SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESK983306SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACINK983309SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACINK983301SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACINK982786TRACCELL 2000 SLIDE MAPPING SYSTEMK972576GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90

View all 12 devices →

Related Devices (Code: JTT)

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.

K935805PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.K895362BACTEC PYRAZINAMIDE SUSCEPTIBILITY TESTBd Becton Dickinson Vacutainer Systems PreanalyticK880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK872081CIPRO (TM) DIAGNOSTIC POWDERMiles PharmaceuticalsK864442NORFLOXACIN SUSCEPTIBILITY POWDERMerck, Sharp & DohmeK860031GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISKOrganon Teknika Corp.

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.

↑