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
1177–1200 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 29, 1996
CAPILLARY ADAPTOR ACCESSORY
K963992 · CGZ
Medica Corp.
Toxicology · 56d
Cleared Nov 29, 1996
WATERS 515 HPLC PUMP (515)
K964588 · KIE
Waters Corporation
Toxicology · 14d
Cleared Nov 26, 1996
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
K961656 · DIH
Eqm Research, Inc.
Toxicology · 210d
Cleared Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Nov 20, 1996
CEDIA PHENYTOIN II ASSAY
K963840 · DIP
Boehringer Mannheim Corp.
Toxicology · 57d
Cleared Oct 31, 1996
EZ-SCREEN PROFILE
K963233 · LCM
Editek, Inc.
Toxicology · 73d
Cleared Oct 30, 1996
CEDIA DAU OPIATE 2K ASSAY
K962795 · DJG
Boehringer Mannheim Corp.
Toxicology · 104d
Cleared Oct 30, 1996
VERDICT THC
K963516 · LDJ
Editek, Inc.
Toxicology · 57d
Cleared Oct 30, 1996
VERDICT BARBITURATES
K963529 · DIS
Editek, Inc.
Toxicology · 56d
Cleared Oct 29, 1996
CEDIA CARDIAC TDM MULTI-CALS
K962269 · JIX
Boehringer Mannheim Corp.
Toxicology · 138d
Cleared Oct 29, 1996
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · LAR
Boehringer Mannheim Corp.
Toxicology · 68d
Cleared Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
K962411 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 108d
Cleared Sep 23, 1996
ACETAMINOPHEN FLEX REAGENT CARTRIDGE
K963244 · LDP
Dade Intl., Inc.
Toxicology · 35d
Cleared Sep 19, 1996
ON.SITE ALCOHOL
K963197 · DML
Ansys, Inc.
Toxicology · 35d
Cleared Sep 16, 1996
DRUG CALIBRATOR II
K962817 · DKB
Dade Intl., Inc.
Toxicology · 59d
Cleared Sep 13, 1996
TOBRAMYCIN FLEX REAGENT CARTRIDGE
K962818 · LCR
Dade Intl., Inc.
Toxicology · 56d
Cleared Sep 13, 1996
GENTAMICIN FLEX REAGENT CARTRIDGE
K962819 · LCD
Dade Intl., Inc.
Toxicology · 56d
Cleared Sep 13, 1996
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820 · KLT
Dade Intl., Inc.
Toxicology · 56d
Cleared Sep 13, 1996
VANCOMYCIN FLEX REAGENT CARTRIDGE
K963267 · LEH
Dade Intl., Inc.
Toxicology · 24d
Cleared Sep 10, 1996
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · LFM
Abbott Laboratories
Toxicology · 46d
Cleared Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
K963191 · DKB
Boehringer Mannheim Corp.
Toxicology · 26d
Cleared Sep 04, 1996
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · LCD
Behring Diagnostics, Inc.
Toxicology · 69d
Cleared Aug 30, 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · JXM
Princeton BioMeditech Corp.
Toxicology · 52d
Cleared Aug 27, 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · LAR
Boehringer Mannheim Corp.
Toxicology · 90d