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
5617–5640 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 25, 1994
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
K923917 · CHI
Nuclear Diagnostics, Inc.
Chemistry · 569d
Cleared Feb 25, 1994
PLATO 3000
K933088 · JQW
Rosys, Inc.
Chemistry · 247d
Cleared Feb 25, 1994
EVATEST STRIP
K936013 · LCX
Boehringer Mannheim Italia Spa
Chemistry · 71d
Cleared Feb 24, 1994
ADVANCE PREGNANCY TEST MODIFICATION
K934516 · LCX
Ortho Pharmaceutical Corp.
Chemistry · 160d
Cleared Feb 24, 1994
SAS(TM) DIRECT MONOCLONAL HCG
K935863 · JHJ
Sa Scientific, Inc.
Chemistry · 83d
Cleared Feb 24, 1994
I-STAT TESTS FOR ACID-BASE PARAMETERS
K936081 · CHL
I-Stat Corp.
Chemistry · 65d
Cleared Feb 18, 1994
CHLORIDE (MF) ASSAY
K934588 · CHG
Diagnostic Chemicals , Ltd.
Chemistry · 148d
Cleared Feb 18, 1994
QUANTAPHASE II B12/FOLATE
K935286 · CGN
Bio-Rad
Chemistry · 137d
Cleared Feb 17, 1994
REFRACTOMETRIC, TOTAL PROTEIN
K933218 · JJX
Pyramid Biological Corp.
Chemistry · 231d
Cleared Feb 03, 1994
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
K935830 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 58d
Cleared Feb 01, 1994
IL TEST CALCIUM
K931362 · CIC
Instrumentation Laboratory CO
Chemistry · 321d
Cleared Jan 31, 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · JFJ
Intersect Systems, Inc.
Chemistry · 231d
Cleared Jan 27, 1994
IMMULITE PAP
K931701 · JFH
Diagnostic Products Corp.
Chemistry · 296d
Cleared Jan 27, 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · JJW
Medical Analysis Systems, Inc.
Chemistry · 99d
Cleared Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
K935181 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Jan 27, 1994
P-AMYLASE CONTROL
K935362 · JJX
Beckman
Chemistry · 84d
Cleared Jan 27, 1994
EVENT TEST STRIP HCG
K935502 · JHI
Boehringer Mannheim Italia Spa
Chemistry · 72d
Cleared Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605 · KLI
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 18, 1994
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
K935018 · JIX
Alko Diagnostic Corp.
Chemistry · 90d
Cleared Jan 18, 1994
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
K935547 · JIX
Alko Diagnostic Corp.
Chemistry · 62d
Cleared Jan 13, 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385 · JIX
Alko Diagnostic Corp.
Chemistry · 444d
Cleared Jan 13, 1994
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
K925464 · JIX
Alko Diagnostic Corp.
Chemistry · 441d
Cleared Jan 13, 1994
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
K930231 · JIX
Alko Diagnostic Corp.
Chemistry · 359d