FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
5017–5040 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 21, 1995
GENESIS
K953345 · JQW
Tecan U.S., Inc.
Chemistry · 132d
Cleared Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 32d
Cleared Nov 20, 1995
CALCITONIN IMMUNOASSAY KIT
K945961 · JKR
Nichols Institute Diagnostics
Chemistry · 348d
Cleared Nov 20, 1995
BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
K952751 · KLI
Biocircuits Corp.
Chemistry · 158d
Cleared Nov 20, 1995
BIOCIRCUITS IOS T4 TEST CARTRIDGE
K953837 · KLI
Biocircuits Corp.
Chemistry · 97d
Cleared Nov 20, 1995
MED-TECH CLINICAL BLOOD GAS
K953935 · CHL
Medical Technical Gases Inc..
Chemistry · 94d
Cleared Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 49d
Cleared Nov 14, 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685 · CDZ
Organon Teknika Corp.
Chemistry · 218d
Cleared Nov 09, 1995
IMMUCHEM GAL-MW EA
K951329 · JIA
Icn Pharmaceuticals, Inc.
Chemistry · 231d
Cleared Nov 09, 1995
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
K952478 · MMI
Boehringer Mannheim Corp.
Chemistry · 163d
Cleared Nov 09, 1995
MAS LIQUID URINALYSIS CONTROL
K954323 · JJY
Medical Analysis Systems, Inc.
Chemistry · 55d
Cleared Nov 09, 1995
ABL SYSTEM 625, 615, 605
K954612 · CHL
Radiometer America, Inc.
Chemistry · 35d
Cleared Nov 08, 1995
FIRST CHOICE(TM) TEST STRIP
K946166 · CGA
Polymer Technology Intl.
Chemistry · 324d
Cleared Nov 08, 1995
FIRST CHOICE TEST STRIP
K950628 · CGA
Polymer Technology Intl.
Chemistry · 268d
Cleared Nov 03, 1995
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE...
K945519 · MPG
Pharmaquest Corp.
Chemistry · 359d
Cleared Nov 03, 1995
PYRILINKS POLYCLONAL ASSAY KIT
K952026 · JMM
Metra Biosystems, Inc.
Chemistry · 186d
Cleared Nov 03, 1995
PYRILINKS ASSAY KIT
K952506 · JMM
Metra Biosystems, Inc.
Chemistry · 156d
Cleared Nov 03, 1995
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · CEW
Nichols Institute Diagnostics
Chemistry · 42d
Cleared Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · JIR
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Oct 25, 1995
ELX808 AUTOMATED MICROPLATE READERS
K953710 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 77d
Cleared Oct 25, 1995
ROCHE REAGENT FOR BUN
K954000 · CDQ
Roche Diagnostic Systems, Inc.
Chemistry · 61d
Cleared Oct 23, 1995
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · KQO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Oct 23, 1995
OSOM PREGNANCY TEST
K954178 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 23, 1995
TRIGLYCERIDES REAGENT
K954187 · JGY
Schiapparelli Biosystems, Inc.
Chemistry · 47d