Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
1561–1584 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Feb 14, 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · LCP
Siemens Heatlhcare Diagnostics, Inc.
Chemistry · 208d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160 · DIO
Roche Diagnostics
Chemistry · 291d
Cleared Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · OUF
Microgenics Corp.
Chemistry · 388d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867 · DJG
Roche Diagnostics
Chemistry · 402d