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
889–912 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · LDJ
Phamatech
Toxicology · 17d
Cleared Feb 01, 2000
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · DML
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · JXN
Syva Co.
Toxicology · 69d
Cleared Jan 27, 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · DKZ
Diagnostic Products Corp.
Toxicology · 174d
Cleared Jan 27, 2000
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · DIP
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · KLT
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · KLS
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · DLZ
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · LAF
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983 · LCM
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · JXM
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · KXS
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · KLT
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · DIO
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
K994017 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
K994020 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030 · LCM
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Jan 24, 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS)...
K993961 · LDJ
American Bio Medica Corp.
Toxicology · 63d
Cleared Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · LAF
Diagnostic Products Corp.
Toxicology · 167d
Cleared Jan 18, 2000
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
K993920 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 61d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · LDJ
Syva Co.
Toxicology · 55d
Cleared Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
K993954 · DKB
Beckman Coulter, Inc.
Toxicology · 50d
Cleared Jan 10, 2000
RADID DRUG SCREEN 5-PANEL TEST
K993151 · DJG
American Bio Medica Corp.
Toxicology · 111d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9073
K994219 · DIO
Phamatech
Toxicology · 15d