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
1537–1560 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 27, 2011
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
K103557 · DCK
Diazyme Laboratories
Chemistry · 146d
Cleared Apr 22, 2011
GSP NEONATAL THYROXINE (T4)
K103484 · KLI
Wallac Oy, A Subsidiary of...
Chemistry · 147d
Cleared Apr 21, 2011
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675 · CDQ
Medica Corp.
Chemistry · 42d
Cleared Apr 20, 2011
UCP DRUG SCREENING TEST CUPS
K110515 · DIS
Ucp Biosciences, Inc.
Chemistry · 56d
Cleared Apr 20, 2011
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
K110436 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 64d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · LAF
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · DKB
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K101746 · LCM
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · DKZ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · LDJ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 07, 2011
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
K110169 · JIT
Siemens Healthcare Diagnostics
Chemistry · 77d
Cleared Apr 04, 2011
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
K101088 · CIX
Medica Corp.
Chemistry · 350d
Cleared Mar 24, 2011
ABL835 FLEX ANALYZER WITH PLEURAL PH
K110416 · CHL
Radiometer Medical Aps
Chemistry · 38d
Cleared Mar 24, 2011
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL...
K102647 · JGS
Elitechgroup Vital Scientific BV
Chemistry · 191d
Cleared Mar 23, 2011
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
K101852 · KQO
Iris International Inc., A Division...
Chemistry · 265d
Cleared Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
K102779 · DJG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
K110412 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 30d
Cleared Mar 16, 2011
IVD-GE02
K101947 · CGA
Sphere Medical , Ltd.
Chemistry · 247d
Cleared Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · CFR
Siemens Healthcare Diagnostics
Chemistry · 249d
Cleared Mar 01, 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · DKZ
Randox Laboratories, Ltd.
Chemistry · 581d
Cleared Feb 18, 2011
FASTPACK TESTO IMMUNOASSAY
K101388 · CDZ
Qualigen, Inc.
Chemistry · 277d
Cleared Feb 17, 2011
TECO DIAGNOSTICS UTI DETECTION STRIPS
K100024 · JMT
Teco Diagnostics
Chemistry · 408d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 48d
Cleared Feb 15, 2011
AFINION ANALYZER
K110056 · LCP
Axis-Shield Poc AS
Chemistry · 36d