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
1057–1080 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 29, 1998
ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST
K980776 · JXM
Tcpi, Inc.
Toxicology · 58d
Cleared Apr 24, 1998
MECTEST
K973986 · DIO
Meco Industries
Toxicology · 186d
Cleared Apr 24, 1998
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES...
K974840 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 121d
Cleared Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853 · DKB
Boehringer Mannheim Corp.
Toxicology · 47d
Cleared Apr 06, 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · DIF
Bio-Rad
Toxicology · 46d
Cleared Apr 02, 1998
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
K980521 · KXT
Bayer Corp.
Toxicology · 64d
Cleared Apr 01, 1998
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12
K974002 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 162d
Cleared Apr 01, 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071,...
K980865 · DKZ
Phamatech
Toxicology · 26d
Cleared Mar 27, 1998
DRUG CHECK
K980153 · DIO
Texas Immunology, Inc.
Toxicology · 70d
Cleared Mar 20, 1998
MICRO-STRIP FOR AMPHETAMINE METABOLITES
K974611 · DKZ
Microdiagnostics, Inc.
Toxicology · 99d
Cleared Mar 20, 1998
RAPID DRUG SCREEN' 8 PANEL
K980872 · DIO
American Bio Medica Corp.
Toxicology · 14d
Cleared Mar 19, 1998
TUMORLOCALIZER MRI
K962615 · MIG
Ferguson Medical
Toxicology · 624d
Cleared Mar 16, 1998
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT...
K980331 · DIF
More Diagnostics
Toxicology · 47d
Cleared Mar 13, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K980249 · LFG
Princeton BioMeditech Corp.
Toxicology · 49d
Cleared Mar 03, 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 57d
Cleared Mar 03, 1998
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · DIS
Syntron Bioresearch, Inc.
Toxicology · 34d
Cleared Mar 02, 1998
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 56d
Cleared Feb 25, 1998
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
K973269 · JXM
Drial Consultants, Inc.
Toxicology · 180d
Cleared Feb 24, 1998
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
K973326 · JXM
Drial Consultants, Inc.
Toxicology · 173d
Cleared Feb 13, 1998
STC CANNABINOIDS MICRO-PLATE EIA
K973750 · LDJ
OraSure Technologies, Inc.
Toxicology · 135d
Cleared Feb 12, 1998
ACS TOBRAMYCIN
K974029 · LCR
Chiron Diagnostics Corp.
Toxicology · 112d
Cleared Feb 12, 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712 · DIS
Syntron Bioresearch, Inc.
Toxicology · 57d
Cleared Feb 12, 1998
2700 SAMPLE MANAGER
K980180 · JQW
Waters Corporation
Toxicology · 23d
Cleared Feb 04, 1998
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582 · LCM
Phamatech
Toxicology · 58d