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
433–456 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 07, 2006
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
K060810 · DKZ
Ind Diagnostic, Inc.
Toxicology · 136d
Cleared Jul 28, 2006
ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
K060354 · JXM
Acro Biotech, LLC
Toxicology · 165d
Cleared Jul 28, 2006
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE,...
K062024 · LFM
Dade Behring, Inc.
Toxicology · 10d
Cleared Jul 25, 2006
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
K060527 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared Jul 21, 2006
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
K051958 · DJG
Mp Biomedicals, LLC
Toxicology · 367d
Cleared Jul 21, 2006
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,
K061556 · LDJ
Amedica Biotech, Inc.
Toxicology · 46d
Cleared Jul 18, 2006
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0...
K061792 · DIC
Dade Behring, Inc.
Toxicology · 22d
Cleared Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · DIH
Roche Diagnostics Corp.
Toxicology · 75d
Cleared Jun 22, 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · DJR
Biosite Incorporated
Toxicology · 91d
Cleared Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
K061503 · DLJ
Dade Behring, Inc.
Toxicology · 21d
Cleared Jun 15, 2006
ACRO BIOTECH LLC RAPID OPIATES URINE TEST
K053037 · DJG
Acro Biotech, LLC
Toxicology · 231d
Cleared Jun 15, 2006
RAPIDONE-COCAINE-150 TEST
K053422 · DIO
American Bio Medica Corp.
Toxicology · 189d
Cleared Jun 15, 2006
MULTIGENT GENTAMICIN
K060709 · LCD
Seradyn, Inc.
Toxicology · 91d
Cleared Jun 09, 2006
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
K052197 · DJR
W.H.P.M., Inc.
Toxicology · 301d
Cleared Jun 09, 2006
ONLINE TDM TOBRAMYCIN
K060853 · KLB
Roche Diagnostics Corp.
Toxicology · 72d
Cleared Jun 09, 2006
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
K060896 · DJC
Varian, Inc.
Toxicology · 67d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST
K053034 · LDJ
Acro Biotech, LLC
Toxicology · 222d
Cleared Jun 02, 2006
AXSYM DIGOXIN III
K061249 · KXT
Abbott Laboratories
Toxicology · 29d
Cleared May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS...
K060645 · DKB
Roche Diagnostics Corp.
Toxicology · 81d
Cleared May 25, 2006
RAPIDTOX
K053359 · DKZ
American Bio Medica Corp.
Toxicology · 174d
Cleared May 18, 2006
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502 · MLM
Dade Behring, Inc.
Toxicology · 83d
Cleared May 18, 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
K060503 · DLJ
Dade Behring, Inc.
Toxicology · 83d
Cleared May 12, 2006
MEDTOX OXYCODONE
K060351 · DJG
Medtox Diagnostics, Inc.
Toxicology · 88d
Cleared May 11, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K060343 · DJZ
Sentech Korea Corp.
Toxicology · 90d