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."
337–360 of 362
Search insights Median review: 54d Cleared: 100% Top manufacturer: Dade Behring, Inc. Lead specialty: Chemistry
Cleared Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · JHX
Dade Behring, Inc.
Chemistry · 58d
Cleared Jan 11, 1999
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT...
K983849 · JHM
Dade Behring, Inc.
Chemistry · 73d
Cleared Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · MMI
Dade Behring, Inc.
Chemistry · 28d
Cleared Dec 14, 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · DDR
Dade Behring, Inc.
Immunology · 28d
Cleared Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · DDR
Dade Behring, Inc.
Immunology · 17d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850 · JIT
Dade Behring, Inc.
Chemistry · 19d
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Dade Behring, Inc.
Chemistry · 14d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Dade Behring, Inc.
Immunology · 18d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871 · DKB
Dade Behring, Inc.
Toxicology · 60d
Cleared Oct 13, 1998
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · GJT
Dade Behring, Inc.
Hematology · 162d
Cleared Sep 30, 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · JPA
Dade Behring, Inc.
Hematology · 156d
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · LEG
Dade Behring, Inc.
Toxicology · 11d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292 · JIT
Dade Behring, Inc.
Chemistry · 44d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · JJX
Dade Behring, Inc.
Chemistry · 12d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Dade Behring, Inc.
Microbiology · 16d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · JJX
Dade Behring, Inc.
Chemistry · 32d
Cleared May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · JHX
Dade Behring, Inc.
Chemistry · 61d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Dade Behring, Inc.
Immunology · 32d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · MMI
Dade Behring, Inc.
Chemistry · 32d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101 · JIT
Dade Behring, Inc.
Chemistry · 20d