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."
169–192 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Dade Behring, Inc.
Microbiology · 317d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Dade Behring, Inc.
Microbiology · 73d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG...
K033809 · KLR
Dade Behring, Inc.
Toxicology · 74d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · DIO
Dade Behring, Inc.
Toxicology · 75d
Cleared Jan 22, 2004
N HIGH SENSITIVITY CRP
K033908 · NQD
Dade Behring, Inc.
Chemistry · 36d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...
K033525 · DCF
Dade Behring, Inc.
Chemistry · 66d
Cleared Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · MMI
Dade Behring, Inc.
Chemistry · 50d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · JIS
Dade Behring, Inc.
Chemistry · 66d
Cleared Oct 31, 2003
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · LAR
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 31, 2003
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · LAN
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 30, 2003
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...
K032798 · JHM
Dade Behring, Inc.
Chemistry · 51d
Cleared Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
K032574 · DKB
Dade Behring, Inc.
Toxicology · 47d
Cleared Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....
K031377 · GKP
Dade Behring, Inc.
Hematology · 130d
Cleared Sep 05, 2003
N/T PROTEIN CONTROL
K032237 · JJY
Dade Behring, Inc.
Immunology · 46d
Cleared Aug 07, 2003
N LATEX IGM
K032014 · CFN
Dade Behring, Inc.
Immunology · 38d
Cleared Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K031602 · LON
Dade Behring, Inc.
Microbiology · 71d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · DIO
Dade Behring, Inc.
Toxicology · 70d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · DKZ
Dade Behring, Inc.
Toxicology · 67d
Cleared Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · CFR
Dade Behring, Inc.
Chemistry · 54d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343 · LTJ
Dade Behring, Inc.
Immunology · 16d
Cleared Feb 13, 2003
N LATEX IGA
K024038 · CZP
Dade Behring, Inc.
Immunology · 69d