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: Toxicology ×
3,029 results
1321–1344 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 02, 1995
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
K950280 · MOJ
Abbott Laboratories
Toxicology · 98d
Cleared May 02, 1995
VISUALINE II CANNABINOIDS (THC)
K950445 · LDJ
Sun Biomedical Laboratories, Inc.
Toxicology · 95d
Cleared May 02, 1995
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · JXN
Microgenics Corp.
Toxicology · 50d
Cleared May 01, 1995
FINGERPRINT-DOA
K942836 · DKZ
Fingerprint Bioteck, Inc.
Toxicology · 320d
Cleared May 01, 1995
IL TEST PHENYTION CALIBRATORS
K943980 · DIP
Instrumentation Laboratory CO
Toxicology · 328d
Cleared Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
K951153 · DLJ
Microgenics Corp.
Toxicology · 38d
Cleared Apr 14, 1995
STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
K950308 · JXS
Solarcare Technologies Corp,Inc.
Toxicology · 79d
Cleared Apr 13, 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · DKZ
Princeton BioMeditech Corp.
Toxicology · 149d
Cleared Apr 13, 1995
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950137 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 90d
Cleared Apr 10, 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983 · KXT
Instrumentation Laboratory CO
Toxicology · 307d
Cleared Apr 05, 1995
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 163d
Cleared Apr 05, 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · DJG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 82d
Cleared Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · LDJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Mar 30, 1995
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 · DKZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Mar 28, 1995
TDX(R)/TDXFLX(R) PHENYTOIN II
K946328 · LGR
Abbott Laboratories
Toxicology · 89d
Cleared Mar 27, 1995
REMEDI HS DRUG PROFILING SYSTEM
K941596 · DNI
Bio-Rad
Toxicology · 360d
Cleared Mar 21, 1995
PRIMIDONE FPIA REAGENT SET AND CALIBRATORS
K950028 · LFT
Sigma Diagnostics, Inc.
Toxicology · 76d
Cleared Mar 21, 1995
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
K950134 · DLN
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 67d
Cleared Mar 21, 1995
URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950182 · DIW
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 63d
Cleared Mar 21, 1995
VISUALINE II COCAINE
K950369 · DIO
Sun Biomedical Laboratories, Inc.
Toxicology · 49d
Cleared Mar 21, 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Mar 20, 1995
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
K941990 · LFI
Bio-Rad
Toxicology · 329d
Cleared Mar 20, 1995
BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
K941994 · LFI
Bio-Rad
Toxicology · 329d
Cleared Mar 20, 1995
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950183 · LCM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 62d