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
745–768 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · DIO
ACON Laboratories, Inc.
Toxicology · 110d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · KXT
Randox Laboratories, Ltd.
Toxicology · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · DLZ
Randox Laboratories, Ltd.
Toxicology · 63d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · KXT
Syva Co., Dade Behring, Inc.
Toxicology · 12d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · LEG
Syva Co.
Toxicology · 11d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · DIO
Teco Diagnostics
Toxicology · 151d
Cleared Jun 25, 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · LDJ
Advantage Diagnostics Corp.
Toxicology · 90d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Microgenics Corp.
Toxicology · 65d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · LAN
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · LBZ
Syva Co., Dade Behring, Inc.
Toxicology · 19d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG
Medtox Diagnostics, Inc.
Toxicology · 21d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · DKZ
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · LAF
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 06, 2001
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
K011057 · PJD
OraSure Technologies, Inc.
Toxicology · 61d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · DJC
Medtox Diagnostics, Inc.
Toxicology · 128d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d