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."
97–120 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · JOZ
Dade Behring, Inc.
Hematology · 147d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818 · JIT
Dade Behring, Inc.
Chemistry · 20d
Cleared Jul 18, 2006
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0...
K061792 · DIC
Dade Behring, Inc.
Toxicology · 22d
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · JWY
Dade Behring, Inc.
Microbiology · 46d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751 · JIT
Dade Behring, Inc.
Chemistry · 22d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702 · JIT
Dade Behring, Inc.
Chemistry · 24d
Cleared Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · LDP
Dade Behring, Inc.
Chemistry · 27d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · CFN
Dade Behring, Inc.
Immunology · 52d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390 · JIX
Dade Behring, Inc.
Chemistry · 48d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · JIX
Dade Behring, Inc.
Chemistry · 60d
Cleared Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · DLJ
Dade Behring, Inc.
Toxicology · 21d
Cleared May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · JIS
Dade Behring, Inc.
Chemistry · 27d
Cleared May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX...
K061238 · KHS
Dade Behring, Inc.
Chemistry · 22d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · DKZ
Dade Behring, Inc.
Chemistry · 169d
Cleared May 18, 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
K060503 · DLJ
Dade Behring, Inc.
Toxicology · 83d
Cleared May 18, 2006
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502 · MLM
Dade Behring, Inc.
Toxicology · 83d
Cleared May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE,...
K061020 · CKA
Dade Behring, Inc.
Chemistry · 27d
Cleared May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · NQD
Dade Behring, Inc.
Chemistry · 80d
Cleared Apr 14, 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE...
K053577 · MMI
Dade Behring, Inc.
Chemistry · 113d
Cleared Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
K060628 · CIG
Dade Behring, Inc.
Chemistry · 28d
Cleared Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK...
K060548 · DHA
Dade Behring, Inc.
Chemistry · 36d
Cleared Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385 · MLM
Dade Behring, Inc.
Chemistry · 51d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · LPS
Dade Behring, Inc.
Chemistry · 177d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · DEB
Dade Behring, Inc.
Immunology · 147d