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
1849–1872 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 18, 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · KLT
Syva Co.
Toxicology · 23d
Cleared Jan 11, 1990
OPUS PHENOBARBITAL TEST SYSTEM
K896861 · DLZ
Pb Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Jan 02, 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · KLT
Pb Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Jan 02, 1990
OPUS PHENYTOIN TEST SYSTEM
K896868 · LGR
Pb Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Dec 19, 1989
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K891691 · DIE
Bio-Rad
Toxicology · 272d
Cleared Dec 19, 1989
TDX(R) BARBITURATES II ASSAY
K896550 · DIS
Abbott Laboratories
Toxicology · 32d
Cleared Dec 07, 1989
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · DIF
Bio-Rad
Toxicology · 69d
Cleared Nov 17, 1989
TARGET OPIATES-R
K890978 · DJG
V-Tech, Inc.
Toxicology · 263d
Cleared Nov 08, 1989
COMA COCAINE METABOLITE ASSAY (EIA)
K895043 · DIO
Serex, Inc.
Toxicology · 91d
Cleared Nov 08, 1989
CEDIA DIGITOXIN ASSAY
K896021 · LFM
Microgenics Corp.
Toxicology · 23d
Cleared Oct 31, 1989
CYBERFLUOR FIAGEN TSH
K895396 · JLW
Cyberfluor, Inc.
Toxicology · 60d
Cleared Oct 31, 1989
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
K895827 · LGR
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Oct 30, 1989
N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
K895572 · DLJ
Tudor Laboratories, Inc.
Toxicology · 54d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN CALIBRATOR SET
K895826 · DLJ
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Oct 30, 1989
INNOFLUOR DIGOXIN REAGENT SET
K895828 · LCS
Innotron of Oregon, Inc.
Toxicology · 28d
Cleared Oct 25, 1989
N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
K895571 · LAN
Tudor Laboratories, Inc.
Toxicology · 49d
Cleared Oct 20, 1989
PRIMIDONE (FPIA) KIT
K895567 · LFT
Tudor Laboratories, Inc.
Toxicology · 44d
Cleared Oct 17, 1989
IQ LDH
K894578 · CFH
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Oct 17, 1989
SOURCERER
K894902 · JJJ
Oakfield Instruments, Ltd.
Toxicology · 77d
Cleared Oct 17, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
K894934 · DKB
Hycor Biomedical, Inc.
Toxicology · 75d
Cleared Oct 13, 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · CDP
Baxter Healthcare Corp
Toxicology · 66d
Cleared Oct 04, 1989
TARGET OPIATES-V
K890979 · DJG
V-Tech, Inc.
Toxicology · 219d
Cleared Oct 04, 1989
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484 · LCD
Baxter Healthcare Corp
Toxicology · 23d
Cleared Oct 03, 1989
VALPROIC ACID (FPIA) KIT
K895569 · LEG
Tudor Laboratories, Inc.
Toxicology · 27d