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
1201–1224 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 20, 1996
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
K951853 · LDJ
Tcpi, Inc.
Toxicology · 487d
Cleared Aug 19, 1996
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · DIO
Princeton BioMeditech Corp.
Toxicology · 62d
Cleared Aug 16, 1996
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 64d
Cleared Aug 15, 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · DIS
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Aug 15, 1996
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · DJR
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Aug 14, 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · LAR
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Jul 22, 1996
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
K962574 · LEQ
Waters Corporation
Toxicology · 21d
Cleared Jul 16, 1996
VALPROIC ACID EIA TEST
K961988 · LEG
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Jul 11, 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K961726 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Jul 08, 1996
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · LDP
Diagnostic Reagents, Inc.
Toxicology · 90d
Cleared Jul 05, 1996
ALLIANCE 2690 SEPARATIONS MODULE
K961557 · LDM
Waters Corporation
Toxicology · 74d
Cleared Jun 28, 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN...
K961010 · DIS
Princeton BioMeditech Corp.
Toxicology · 107d
Cleared Jun 27, 1996
CEDIA THEOPHYLLINE ASSAY
K961462 · KLS
Boehringer Mannheim Corp.
Toxicology · 71d
Cleared Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
K962165 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jun 21, 1996
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
K961436 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 67d
Cleared Jun 18, 1996
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · JHY
Bayer Corp.
Toxicology · 67d
Cleared Jun 13, 1996
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
K961620 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
K961659 · JIX
Boehringer Mannheim Corp.
Toxicology · 44d
Cleared Jun 12, 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP,...
K961325 · JXM
Princeton BioMeditech Corp.
Toxicology · 65d
Cleared Jun 12, 1996
TRICYCLICS SERUM TOX ASSAY
K961393 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Jun 03, 1996
U-DOA CONTROLS
K961724 · DIF
Medical Diagnostic Technologies, Inc.
Toxicology · 31d
Cleared May 31, 1996
ACCUSIGN, BIOSIGN PCP
K961266 · LCM
Princeton BioMeditech Corp.
Toxicology · 59d
Cleared May 24, 1996
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 165d
Cleared May 20, 1996
BENZODIAZEPINE SERUM TOX EIA TEST
K960708 · JXM
Diagnostic Reagents, Inc.
Toxicology · 89d