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
1105–1128 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 25, 1997
ALCOHOL REAGENT SET
K972725 · DIC
Pointe Scientific, Inc.,
Toxicology · 66d
Cleared Sep 25, 1997
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · LDJ
Phamatech
Toxicology · 36d
Cleared Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
K972963 · LCM
Boehringer Mannheim Corp.
Toxicology · 42d
Cleared Sep 22, 1997
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · DJR
Beckman Instruments, Inc.
Toxicology · 35d
Cleared Sep 12, 1997
WAKO NEFA LINEARITY SET
K973072 · JJX
Wako Chemicals USA, Inc.
Toxicology · 25d
Cleared Sep 12, 1997
LIDOCAINE EIA ASSAY
K973102 · KLR
Diagnostic Reagents, Inc.
Toxicology · 24d
Cleared Sep 09, 1997
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640 · DOF
Esa, Inc.
Toxicology · 130d
Cleared Sep 02, 1997
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · LAF
Phamatech
Toxicology · 55d
Cleared Aug 28, 1997
QUIKPAC II ONE STEP COCAINE TEST
K972059 · DIO
Drial Consultants, Inc.
Toxicology · 87d
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Aug 20, 1997
QUIKSTRIP ONE STEP OPIATES TEST
K972571 · DJG
Drial Consultants, Inc.
Toxicology · 41d
Cleared Aug 20, 1997
QUICK SCREEN ONE STEP AMPHETAMINE TEST
K972577 · DIT
Phamatech
Toxicology · 41d
Cleared Aug 20, 1997
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · DJG
Phamatech
Toxicology · 40d
Cleared Aug 13, 1997
VIGIL TDM CONTROLS
K972819 · DIF
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Aug 12, 1997
VISUALINE II METHAMPHETIMINE
K972032 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 71d
Cleared Aug 08, 1997
QUIKPAC II ONE STEP OPIATE TEST
K972405 · DJG
Drial Consultants, Inc.
Toxicology · 43d
Cleared Aug 08, 1997
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
K972618 · DMN
Phamatech
Toxicology · 28d
Cleared Aug 06, 1997
AQ ONE STEP COCAINE TEST
K972384 · DIO
Bionike Laboratories, Inc.
Toxicology · 41d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526 · DJR
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Aug 01, 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · LGQ
Oxis Intl., Inc.
Toxicology · 39d
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · KXT
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC...
K972132 · LEG
Sigma Diagnostics, Inc.
Toxicology · 54d
Cleared Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433 · DLJ
Boehringer Mannheim Corp.
Toxicology · 24d
Cleared Jul 22, 1997
OPUS ETHANOL
K972011 · DIC
Behring Diagnostics, Inc.
Toxicology · 53d