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."
265–288 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · KLT
Syva Co., Dade Behring, Inc.
Toxicology · 25d
Cleared Apr 13, 2001
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
K010812 · LAR
Syva Co., Dade Behring, Inc.
Chemistry · 25d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · KHS
Dade Behring, Inc.
Chemistry · 52d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · JIT
Dade Behring, Inc.
Chemistry · 122d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Dade Behring, Inc.
Chemistry · 65d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Dade Behring, Inc.
Chemistry · 120d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Dade Behring, Inc.
Immunology · 68d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Dade Behring, Inc.
Chemistry · 28d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · GJS
Dade Behring, Inc.
Hematology · 67d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · DCN
Dade Behring, Inc.
Immunology · 104d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Dade Behring, Inc.
Chemistry · 56d
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · DJG
Dade Behring, Inc.
Toxicology · 53d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Dade Behring, Inc.
Chemistry · 75d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731 · JZG
Dade Behring, Inc.
Immunology · 80d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Dade Behring, Inc.
Hematology · 129d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Dade Behring, Inc.
Chemistry · 27d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Dade Behring, Inc.
Hematology · 41d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Aug 04, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · GKP
Dade Behring, Inc.
Hematology · 66d
Cleared Jun 21, 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · JPA
Dade Behring, Inc.
Hematology · 79d
Cleared Jun 20, 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · JPA
Dade Behring, Inc.
Hematology · 78d