510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964009Substantially Equivalent

Immage Immunochemistry System Gentamicin(gen)/tobramycin(tob) Reagent / Beckman Drug Claibrator 3 Plus

Beckman Instruments, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964009 is the FDA 510(k) clearance record for IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS, a class II device, cleared for Beckman Instruments, Inc. on under FDA product code DNO (Hemagglutination Inhibition, Gentamicin). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K964009.

Clearance record

Decision date
Received
(127 days to decision)
Product code
DNO Hemagglutination Inhibition, Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Beckman Instruments, Inc. 2470 Faraday, Carlsbad CA
510(k) summary
Summary
Third party review
No

Clearances, product code DNO

Trailing 12 months

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

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