INNOFLOUR TOBRAMYCIN— 510(k) K841866

Substantially Equivalent

Innotron Diagnostics

FDA 510(k) clearance K841866 for INNOFLOUR TOBRAMYCIN, Substantially Equivalent on 1984-05-31. Applicant: Innotron Diagnostics. Device class: 2.

Clearance details

Applicant: Innotron Diagnostics
Product code: Code LFW
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1984-05-04
Decision date: 1984-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFW

K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN1997-02-04
K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR1994-11-10
K941614 — AXSYM TOBRAMYCIN1994-08-18
K912143 — CEDIA(R) TOBRAMYCIN ASSAY1991-07-26
K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR1990-04-20

More clearances from Innotron Diagnostics

K850629 — INNOFLUOR THEOPHYLLINE1985-03-12
K844721 — INNOFLUOR PRIMIDONE1985-01-08
K841865 — INNOFLOUR GENTAMICIN1984-05-31
K841707 — INNOFLUOR PHENOBARBITAL1984-05-23
K841706 — INNOFLUOR PHENYTOIN1984-05-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.