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."
193–216 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · JPA
Dade Behring, Inc.
Hematology · 118d
Cleared Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
K022976 · DAP
Dade Behring, Inc.
Hematology · 132d
Cleared Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN...
K023361 · LON
Dade Behring, Inc.
Microbiology · 70d
Cleared Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
K023541 · LON
Dade Behring, Inc.
Microbiology · 52d
Cleared Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
K022977 · DAP
Dade Behring, Inc.
Hematology · 82d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312 · GGC
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309 · GIZ
Dade Behring, Inc.
Hematology · 29d
Cleared Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K023065 · MKW
Dade Behring, Inc.
Chemistry · 30d
Cleared Aug 27, 2002
PROTEIN S AC
K022290 · GGP
Dade Behring, Inc.
Hematology · 43d
Cleared Jul 17, 2002
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020413 · LON
Dade Behring, Inc.
Microbiology · 160d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · GKP
Dade Behring, Inc.
Hematology · 93d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · JIT
Dade Behring, Inc.
Immunology · 87d
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64...
K020410 · LON
Dade Behring, Inc.
Microbiology · 124d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared May 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K020398 · LON
Dade Behring, Inc.
Microbiology · 99d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692 · LEH
Dade Behring, Inc.
Toxicology · 67d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · MRR
Dade Behring, Inc.
Chemistry · 64d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · DLJ
Dade Behring, Inc.
Toxicology · 54d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared May 08, 2002
DIMENSION ALDL CALIBRATOR, MODEL DC131
K020723 · JIT
Dade Behring, Inc.
Chemistry · 63d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN...
K020397 · LON
Dade Behring, Inc.
Microbiology · 75d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d