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
721–744 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · DIF
Biosite Incorporated
Toxicology · 27d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT
Diagnostic Products Corp.
Toxicology · 61d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · LCD
Randox Laboratories, Ltd.
Toxicology · 74d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · JXM
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · DKB
Randox Laboratories, Ltd.
Toxicology · 51d
Cleared Sep 04, 2001
MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET...
K012541 · LDJ
Branan Medical Corp.
Toxicology · 28d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · DKZ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · KLB
Diagnostic Products Corp.
Toxicology · 28d
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID...
K011878 · DKJ
Syva Co.
Toxicology · 59d
Cleared Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE...
K011730 · LCM
ACON Laboratories, Inc.
Toxicology · 65d
Cleared Aug 09, 2001
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962 · DIO
Advantage Diagnostics Corp.
Toxicology · 48d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522 · JHI
Sa Scientific, Inc.
Toxicology · 159d
Cleared Jul 31, 2001
METHADONE MICROPLATE EIA URINE APPLICATION
K011131 · DJR
Cozart Bioscience , Ltd.
Toxicology · 109d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP...
K011672 · LAF
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST...
K011673 · DKZ
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Jul 30, 2001
RADS
K011054 · DIO
Chason Healthcare, LLC
Toxicology · 115d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Jul 25, 2001
RAPID DRUG SCREEN
K012159 · DKZ
American Bio Medica Corp.
Toxicology · 33d
Cleared Jul 20, 2001
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
K012107 · LCM
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Jul 20, 2001
LIVESURE BENZODIAZEPINES SCREEN TESTS
K012131 · JXM
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
LIVESURE BARBITURATES SCREEN TEST
K012133 · DIS
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 17, 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 63d