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
2065–2088 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 13, 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
K874267 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR MORPHINE TEST KIT
K874268 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR LSD TEST KIT
K874270 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR COCAINE/COCAINE META. TEST
K874271 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874273 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874274 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 09, 1987
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 03, 1987
CANNABINOID ENZYME IMMUNOASSAY KIT
K872882 · LDJ
General Diagnostics
Toxicology · 104d
Cleared Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
K873426 · KLP
Em Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Oct 29, 1987
EMIT QST GENTAMICIN ASSAY
K873855 · LCD
Syva Co.
Toxicology · 37d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA OPIATE ASSAYS
K873898 · DJG
Syva Co.
Toxicology · 35d
Cleared Oct 29, 1987
REVISED LABELING FOR SYVA AMPHETAMINE ASSAY
K874080 · DKZ
Syva Co.
Toxicology · 23d
Cleared Oct 28, 1987
CARBAMAZEPINE (FPIA) CALIBRATOR KIT
K873281 · DLJ
Windsor Laboratories, Inc.
Toxicology · 72d
Cleared Oct 28, 1987
EMIT GENTAMICIN ASSAY
K873854 · LCD
Syva Co.
Toxicology · 36d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHADONE ASSAYS
K873899 · DJR
Syva Co.
Toxicology · 34d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079 · LDJ
Syva Co.
Toxicology · 22d
Cleared Oct 28, 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · LDJ
Syva Co.
Toxicology · 15d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS
K874199 · KXS
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS
K874200 · JXN
Syva Co.
Toxicology · 14d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY
K874201 · DIO
Syva Co.
Toxicology · 14d
Cleared Oct 20, 1987
BAKER TDM THEOPHYLLINE ASSAY
K873596 · KLS
Baker Instructions Corp.
Toxicology · 46d