CEDIA(R) TOBRAMYCIN ASSAY— 510(k) K912143

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K912143 for CEDIA(R) TOBRAMYCIN ASSAY, Substantially Equivalent on 1991-07-26. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LFW
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1991-05-15
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFW

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K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR1994-11-10
K941614 — AXSYM TOBRAMYCIN1994-08-18
K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR1990-04-20
K894531 — FPR TOBRAMYCIN KIT1989-09-01

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K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO2011-06-29
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Recalls naming K912143

K-number listed on FDA's recall record

Z-0513-2014 — Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.Class II·Terminated·Microgenics Corp·20131016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912143.

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