510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170081Unknown

MALDI Biotyper CA System

Bruker Daltonik GmbH, Bremen, DE / Direct, Unknown
FDA source (opens on fda.gov)

DEN170081 is the FDA 510(k) clearance record for MALDI Biotyper CA System, a class II device, cleared for Bruker Daltonik GmbH on under FDA product code QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates). FDA's definition for product code QBN reads: "The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI...". FDA records list 3 510(k) clearances for Bruker Daltonik GmbH, from to . As of , FDA records show no recalls naming DEN170081.

Clearance record

Decision date
Received
(203 days to decision)
Product code
QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Regulation
21 CFR 866.3378
Device class
Class II
Review panel
Microbiology
Applicant
Bruker Daltonik GmbH Fahrenheitstrasse 4, Bremen, DE
Third party review
No

Clearances, product code QBN

Trailing 12 months

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

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