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
4417–4440 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
K971761 · JJE
Biochem Immunosystems (U.S.), Inc.
Chemistry · 71d
Cleared Jul 22, 1997
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · LBS
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Jul 20, 1997
BUN (LIQUID) REAGENT SET
K972671 · CDQ
Pointe Scientific, Inc.,
Chemistry · 4d
Cleared Jul 17, 1997
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K971418 · MOI
Chiron Diagnostics Corp.
Chemistry · 92d
Cleared Jul 17, 1997
CREATINE KINASE (CK)
K972155 · CGS
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 17, 1997
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K972297 · JFJ
Trace America, Inc.
Chemistry · 28d
Cleared Jul 14, 1997
ACS DIGITOXIN
K970546 · LFM
Chiron Diagnostics Corp.
Chemistry · 152d
Cleared Jul 14, 1997
CREATINE KINASE-MB REAGENT SET
K971566 · CGS
Horizon Diagnostics, Inc.
Chemistry · 76d
Cleared Jul 07, 1997
PRECINORM TDM CONTROLS
K971060 · DIF
Boehringer Mannheim Corp.
Chemistry · 105d
Cleared Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
K972287 · JJX
Dade Intl., Inc.
Chemistry · 18d
Cleared Jun 30, 1997
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · JQW
Pharmacia, Inc.
Chemistry · 147d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · KHO
Tosoh Medics, Inc.
Chemistry · 93d
Cleared Jun 27, 1997
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · LAR
Bayer Corp.
Chemistry · 49d
Cleared Jun 26, 1997
SYNERMED IR 200 CHEMISTRY ANALYZER
K971491 · JJF
Synermed, Inc.
Chemistry · 63d
Cleared Jun 26, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
K972070 · JJY
Nichols Institute Diagnostics
Chemistry · 23d
Cleared Jun 24, 1997
THYROTROPIN(TSH) ELISA
K971780 · JLW
Monobind
Chemistry · 41d
Cleared Jun 24, 1997
CALCIUM REAGENT
K971907 · CIC
Carolina Liquid Chemistries Corp.
Chemistry · 32d
Cleared Jun 24, 1997
PROLACTIN (PRL) HORMONE MICROPLATE ELISA
K971921 · CFT
Monobind
Chemistry · 32d
Cleared Jun 24, 1997
TOTAL BILIRUBIN REAGENT
K972073 · CIG
Carolina Liquid Chemistries Corp.
Chemistry · 21d
Cleared Jun 24, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070),...
K972133 · JLS
Johnson & Johnson Clinical...
Chemistry · 18d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · JJY
Roche Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Jun 24, 1997
ABBOTT AXSYM FOLATE
K972232 · CGN
Abbott Laboratories
Chemistry · 8d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · CGA
Selfcare, Inc.
Chemistry · 114d
Cleared Jun 20, 1997
CHOLESTEROL REAGENT
K971072 · CHH
Derma Media Lab., Inc.
Chemistry · 88d