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
649–672 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 10, 2002
STARTOX DRUG OF ABUSE SCREENING TEST
K021006 · DKZ
Starplex Scientific, Inc.
Toxicology · 74d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654 · JJF
Precision Systems, Inc.
Toxicology · 211d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368 · DJG
Lin-Zhi International, Inc.
Toxicology · 120d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041...
K020395 · DKZ
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · DKZ
Biosite Incorporated
Toxicology · 159d
Cleared May 23, 2002
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET,...
K014192 · MVO
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 23, 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · LDJ
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · DIO
ACON Laboratories, Inc.
Toxicology · 68d
Cleared May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · LCM
Lin-Zhi International, Inc.
Toxicology · 106d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692 · LEH
Dade Behring, Inc.
Toxicology · 67d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031...
K020763 · DIO
Lin-Zhi International, Inc.
Toxicology · 64d
Cleared May 08, 2002
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD
K020313 · DKZ
Acon Laboratories Co.
Toxicology · 98d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · DLJ
Dade Behring, Inc.
Toxicology · 54d
Cleared May 06, 2002
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG...
K020716 · DJG
Rapid Diagnostics, Inc.
Toxicology · 62d
Cleared May 03, 2002
PSYCHEMEDICS RIA CANNABINOID ASSAY
K011426 · LAT
Psychemedics Corp.
Toxicology · 360d
Cleared May 02, 2002
VERDICT-II PROPOXYPHENE
K020787 · JXN
Medtox Diagnostics, Inc.
Toxicology · 52d
Cleared Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089 · DIS
Sun Biomedical Laboratories, Inc.
Toxicology · 135d
Cleared Apr 17, 2002
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K013882 · JXM
OraSure Technologies, Inc.
Toxicology · 145d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · KLS
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371 · DJG
OraSure Technologies, Inc.
Toxicology · 58d
Cleared Apr 03, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · DLJ
Lin-Zhi International, Inc.
Toxicology · 27d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · DIO
Dade Behring, Inc.
Toxicology · 45d
Cleared Mar 20, 2002
BARBITURATES
K012996 · DIS
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
METHADONE
K013001 · DJR
Abbott Laboratories
Toxicology · 195d