510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962818Substantially Equivalent

Tobramycin Flex Reagent Cartridge

Dade Intl., Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962818 is the FDA 510(k) clearance record for TOBRAMYCIN FLEX REAGENT CARTRIDGE, a class II device, cleared for Dade Intl., Inc. on under FDA product code LCR (Fluorescent Immunoassay, Tobramycin). FDA records list 30 510(k) clearances for Dade Intl., Inc., from to . As of , FDA records show no recalls naming K962818.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LCR Fluorescent Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Intl., Inc. Bldg. 500 Mail Box 514, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code LCR

Trailing 12 months

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

FDA records show no clearances under product code LCR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCR, 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