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)

CEFTRIAXONE 30 MCG SENSI-DISC

K-Number: K850358 · 1985-03-20

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1985-03-20
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFTRIAXONE 30 MCG SENSI-DISC is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1985-03-20 under 510(k) number K850358. 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 CEFTRIAXONE 30 MCG SENSI-DISC?

CEFTRIAXONE 30 MCG SENSI-DISC is a medical device that received FDA 510(k) clearance on 1985-03-20. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K850358.

When did CEFTRIAXONE 30 MCG SENSI-DISC receive FDA 510(k) clearance?

CEFTRIAXONE 30 MCG SENSI-DISC received FDA 510(k) clearance on 1985-03-20, under 510(k) number K850358.

Who is the listed applicant for CEFTRIAXONE 30 MCG SENSI-DISC?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEFTRIAXONE 30 MCG SENSI-DISC?

The FDA product code for CEFTRIAXONE 30 MCG SENSI-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 Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 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.

↑