510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912143Substantially Equivalent

Cedia(r) Tobramycin Assay

Microgenics Corporation, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912143 is the FDA 510(k) clearance record for CEDIA(R) TOBRAMYCIN ASSAY, a class II device, cleared for Microgenics Corp. on under FDA product code LFW (Fluorescence Polarization Immunoassay, Tobramycin). FDA records list 128 510(k) clearances for Microgenics Corp., from to . As of , FDA records show 2 recalls naming K912143.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LFW Fluorescence Polarization Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Microgenics Corp. 2380a Bisso Ln., Concord CA
510(k) summary
Statement
Third party review
No

Clearances, product code LFW

Trailing 12 months

FDA records hold no clearances under product code LFW in the trailing twelve months.

FDA records show no clearances under product code LFW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260