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
1873–1896 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 28, 1989
EZ-BEAD DIGOXIN EIA KIT
K893843 · KXT
Immunotech Corp.
Toxicology · 126d
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222 · JJE
Abbott Laboratories
Toxicology · 101d
Cleared Sep 28, 1989
FPR AMIKACIN KIT
K894517 · KLQ
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR AMIKACIN CALIBRATOR KIT
K894518 · DLG
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR GENTAMICIN KIT
K894523 · LCQ
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR GENTAMICIN CALIBRATOR KIT
K894524 · DLG
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
PRIMIDONE (FPIA) CALIBRATOR KIT
K895568 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 28, 1989
VALPROIC ACID (FPIA) CALIBRATOR KIT
K895570 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 25, 1989
FPR DIGOXIN KIT
K894521 · KXT
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR DIGOXIN CALIBRATOR KIT
K894522 · DLJ
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR PHENYTOIN KIT
K894527 · DLP
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
FPR PHENYTOIN CALIBRATOR KIT
K894528 · DLG
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210 · DKZ
Abbott Laboratories
Toxicology · 38d
Cleared Sep 18, 1989
FPR THEOPHYLLINE CALIBRATOR KIT
K894530 · DLJ
Colony Laboratories, Inc.
Toxicology · 60d
Cleared Sep 15, 1989
FPR THEOPHYLLINE KIT
K894529 · LGS
Colony Laboratories, Inc.
Toxicology · 57d
Cleared Sep 01, 1989
FPR TOBRAMYCIN KIT
K894531 · LFW
Colony Laboratories, Inc.
Toxicology · 43d
Cleared Sep 01, 1989
FPR TOBRAMYCIN CALIBRATOR KIT
K894532 · DLJ
Colony Laboratories, Inc.
Toxicology · 43d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE KIT
K894519 · KLT
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE CALIBRATOR KIT
K894520 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL KIT
K894525 · LGQ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL CALIBRATOR KIT
K894526 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688 · LCM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM OPIATES
K890689 · DGJ
Abbott Laboratories
Toxicology · 192d