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
4537–4560 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 26, 1997
MAGNESIUM
K964915 · JGJ
Derma Media Lab., Inc.
Chemistry · 107d
Cleared Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
K964841 · JLS
Boehringer Mannheim Corp.
Chemistry · 111d
Cleared Mar 24, 1997
AXSYM B12
K965186 · CDD
Abbott Laboratories
Chemistry · 90d
Cleared Mar 24, 1997
BILE ACIDS REAGENT SET
K970120 · KWW
Teco Diagnostics
Chemistry · 69d
Cleared Mar 24, 1997
CHIRON DIAGNOSTICS ACS:180TU P
K970539 · KHQ
Chiron Diagnostics Corp.
Chemistry · 40d
Cleared Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408 · CEC
Nichols Institute Diagnostics
Chemistry · 270d
Cleared Mar 18, 1997
GENESIS RMP
K963268 · JRA
Tecan U.S., Inc.
Chemistry · 210d
Cleared Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
K964889 · CDZ
Boehringer Mannheim Corp.
Chemistry · 102d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4...
K965142 · CEC
Johnson & Johnson Clinical...
Chemistry · 85d
Cleared Mar 18, 1997
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
K970467 · CEP
Excel Scientific, Inc.
Chemistry · 39d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL...
K970643 · CHP
Johnson & Johnson Clinical...
Chemistry · 26d
Cleared Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723 · LBR
Trace America, Inc.
Chemistry · 241d
Cleared Mar 11, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
K965058 · CDP
Nichols Institute Diagnostics
Chemistry · 83d
Cleared Mar 11, 1997
URIC ACID (LIQUID) REAGENT SET
K970560 · KNK
Pointe Scientific, Inc.,
Chemistry · 26d
Cleared Mar 10, 1997
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT,...
K965240 · JJE
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 10, 1997
HUMAN CHORIONIC GONADOTROPIN METHOD
K970387 · DHA
Dade Chemistry Systems, Inc.
Chemistry · 35d
Cleared Mar 10, 1997
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
K970477 · CFE
Sebia
Chemistry · 31d
Cleared Mar 10, 1997
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
K970666 · DIF
Bio-Rad
Chemistry · 14d
Cleared Mar 06, 1997
CR PERFECT
K970087 · CGX
Chimera Research & Chemical, Inc.
Chemistry · 55d
Cleared Mar 06, 1997
LIPASE REAGENT SET (COLIPASE METHOD)
K970124 · CET
Teco Diagnostics
Chemistry · 51d
Cleared Mar 06, 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424 · JHI
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 06, 1997
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
K970425 · LCX
Excel Scientific, Inc.
Chemistry · 30d
Cleared Mar 03, 1997
SYNERMED ISE REAGENTS
K962479 · CGZ
Synermed, Inc.
Chemistry · 250d
Cleared Mar 03, 1997
MMB CALIBRATOR
K970336 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 33d