Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

362 results for "Dade Behring, Inc."
1–24 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · GGN
Dade Behring, Inc.
Hematology · 369d
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081161 · CFN
Dade Behring, Inc.
Immunology · 95d
Cleared Jul 21, 2008
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081249 · DEB
Dade Behring, Inc.
Immunology · 80d
Cleared Jun 25, 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · DHX
Dade Behring, Inc.
Immunology · 379d
Cleared Jun 04, 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION...
K071597 · LOJ
Dade Behring, Inc.
Immunology · 358d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT...
K073604 · CEC
Dade Behring, Inc.
Chemistry · 83d
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION...
K073561 · CFN
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · JHM
Dade Behring, Inc.
Chemistry · 113d
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · JFY
Dade Behring, Inc.
Chemistry · 65d
Cleared Dec 21, 2007
DIMENSION VISTA C1 IN
K072965 · DBA
Dade Behring, Inc.
Immunology · 60d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · JIT
Dade Behring, Inc.
Chemistry · 78d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4...
K071224 · CDD
Dade Behring, Inc.
Chemistry · 195d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1...
K072435 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
K072304 · GFX
Dade Behring, Inc.
Hematology · 33d
Cleared Sep 11, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · JJY
Dade Behring, Inc.
Immunology · 55d
Cleared Aug 24, 2007
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · DIC
Dade Behring, Inc.
Toxicology · 52d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071317 · LON
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 20, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW...
K071316 · LRG
Dade Behring, Inc.
Microbiology · 102d
Cleared Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · NBC
Dade Behring, Inc.
Chemistry · 45d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247 · DHR
Dade Behring, Inc.
Immunology · 96d
Cleared Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · NBC
Dade Behring, Inc.
Chemistry · 36d
Cleared Jul 18, 2007
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346 · LON
Dade Behring, Inc.
Microbiology · 162d
Cleared Jun 26, 2007
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268 · LON
Dade Behring, Inc.
Microbiology · 50d
Cleared Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · DIC
Dade Behring, Inc.
Chemistry · 77d