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
961–984 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 24, 1999
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
K990325 · DKZ
Syntron Bioresearch, Inc.
Toxicology · 142d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · DIS
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · JXM
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 18, 1999
STATUS CUP ACCUSIGN CUP
K991751 · DKE
Princeton BioMeditech Corp.
Toxicology · 25d
Cleared Jun 11, 1999
AT HOME DRUG TEST, MODEL 9171
K991824 · MVO
Phamatech
Toxicology · 15d
Cleared Jun 01, 1999
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
K991641 · MVO
Phamatech
Toxicology · 20d
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 194d
Cleared Apr 27, 1999
REDI-TEST THC
K990870 · LDJ
Redwood Biotech, Inc.
Toxicology · 42d
Cleared Apr 16, 1999
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
K990928 · DIE
Bio-Rad
Toxicology · 28d
Cleared Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · DKZ
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
K990409 · DMY
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3,...
K991076 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8,...
K991078 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · JXM
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN MTD, BIOSIGN MTD
K991080 · DJR
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA...
K991082 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084 · DIS
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 13, 1999
ONTRAK TESTCUP-ER M2K
K990418 · DKZ
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · LFM
Dade Behring, Inc.
Toxicology · 63d
Cleared Mar 31, 1999
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · DNN
Emd Chemicals, Inc.
Toxicology · 41d
Cleared Mar 26, 1999
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN...
K990786 · LAG
Princeton BioMeditech Corp.
Toxicology · 16d
Cleared Mar 01, 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
K983790 · LCM
Sun Biomedical Laboratories, Inc.
Toxicology · 125d
Cleared Feb 26, 1999
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST
K984525 · DKZ
American Bio Medica Corp.
Toxicology · 67d