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
1153–1176 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916 · LDJ
Diagnostic Products Corp.
Toxicology · 210d
Cleared Apr 25, 1997
PARAMAX SALICYLATE REAGENT
K964715 · DKJ
Dade Intl., Inc.
Toxicology · 151d
Cleared Apr 17, 1997
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · LAS
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Apr 14, 1997
RAPID DRUG SCREEN
K964900 · DIO
American Bio Medica Corp.
Toxicology · 138d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918 · DIO
Diagnostic Products Corp.
Toxicology · 190d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · DKZ
Drial Consultants, Inc.
Toxicology · 75d
Cleared Mar 10, 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · DJG
Diagnostic Products Corp.
Toxicology · 266d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · LDJ
Syntron Bioresearch, Inc.
Toxicology · 169d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · LDJ
Drial Consultants, Inc.
Toxicology · 189d
Cleared Feb 14, 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765 · KLT
Chiron Diagnostics Corp.
Toxicology · 79d
Cleared Feb 11, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT /...
K964009 · DNO
Beckman Instruments, Inc.
Toxicology · 127d
Cleared Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670 · LFW
Roche Diagnostic Systems, Inc.
Toxicology · 75d
Cleared Feb 04, 1997
DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
K964771 · DIF
Dyna-Tek Industries
Toxicology · 69d
Cleared Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
K965157 · DIF
Boehringer Mannheim Corp.
Toxicology · 25d
Cleared Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · LEH
Bayer Corp.
Toxicology · 59d
Cleared Dec 18, 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · LBZ
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Dec 13, 1996
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062 · KXT
Beckman Instruments, Inc.
Toxicology · 128d
Cleared Dec 13, 1996
NICCHECK I
K963733 · MRS
Dynagen, Inc.
Toxicology · 88d
Cleared Dec 13, 1996
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · KLT
Bayer Corp.
Toxicology · 64d
Cleared Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 42d
Cleared Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
K962734 · JXM
Boehringer Mannheim Corp.
Toxicology · 148d
Cleared Dec 10, 1996
VERDICT PCP
K963692 · LCM
Editek, Inc.
Toxicology · 85d
Cleared Dec 10, 1996
DIGOXIN ENZYME IMMUNOASSAY
K963835 · KXT
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Nov 29, 1996
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
K963693 · CEP
Princeton BioMeditech Corp.
Toxicology · 74d