510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843828Substantially Equivalent

Cobas Reagents for Tobramycin & Calibra

Roche Diagnostic Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843828 is the FDA 510(k) clearance record for COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code LFW (Fluorescence Polarization Immunoassay, Tobramycin). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K843828.

Clearance record

Decision date
Received
(126 days to decision)
Product code
LFW Fluorescence Polarization Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
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