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
5785–5808 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 08, 1993
UIBC FOR DISCREET RANDOM ACCESS ANALYZER
K932871 · CFM
Catachem, Inc.
Chemistry · 86d
Cleared Sep 08, 1993
OPUS ESTRADIOL
K933066 · CHP
Pb Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Sep 08, 1993
OPUS TOTAL CK
K933675 · CGS
Pb Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Sep 01, 1993
AMNIOTEST(TM)
K914419 · HIO
Pro-Lab, Inc.
Chemistry · 699d
Cleared Aug 31, 1993
OLYMPUS REPLY GLUCOSE REAGENT
K931744 · JJE
Olympus Corp.
Chemistry · 147d
Cleared Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · CDX
Baxter Diagnostics, Inc.
Chemistry · 44d
Cleared Aug 25, 1993
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · JIS
King Diagnostics, Inc.
Chemistry · 152d
Cleared Aug 25, 1993
TRIGLYCERIDES
K931891 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 132d
Cleared Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · CDD
Bio-Rad
Chemistry · 49d
Cleared Aug 23, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K930104 · JIX
Schiapparelli Biosystems, Inc.
Chemistry · 224d
Cleared Aug 19, 1993
OMNI
K925625 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 286d
Cleared Aug 19, 1993
SIA THYROID STIMULATING HORMONE ELISA KIT
K930050 · JLW
Sigma Chemical Co.
Chemistry · 226d
Cleared Aug 19, 1993
COBAS CORE PROLACTIN EIA
K930305 · CFT
Roche Diagnostic Systems, Inc.
Chemistry · 210d
Cleared Aug 19, 1993
ETHYLIDENE AMYL
K931582 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
SILYL AMYL
K931583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Aug 19, 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745 · CDQ
Olympus Corp.
Chemistry · 136d
Cleared Aug 19, 1993
DC-LINEATE CAT. NO. SE-091
K932555 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 85d
Cleared Aug 19, 1993
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
K932674 · KQO
Miles Inc., Dental Products
Chemistry · 78d
Cleared Aug 19, 1993
CIBA CORNING 300 SERIES SYSTEM
K933373 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 38d
Cleared Aug 16, 1993
IMMULITE TSH THIRD GENERATION CONTROL
K930007 · JJX
Diagnostic Products Corp.
Chemistry · 224d
Cleared Aug 16, 1993
IMMULITE FREE T4
K931704 · CEC
Diagnostic Products Corp.
Chemistry · 132d
Cleared Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · CHP
Bio-Rad
Chemistry · 131d
Cleared Aug 16, 1993
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · LBR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Aug 11, 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317 · JJY
Bio-Rad
Chemistry · 35d