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
1561–1584 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 22, 1993
THE TRIAGE II
K924476 · DKZ
Biosite Incorporated
Toxicology · 141d
Cleared Jan 21, 1993
ETHYL ALCOHOL ASSAY
K923783 · DMT
Diagnostic Reagents, Inc.
Toxicology · 177d
Cleared Jan 13, 1993
FAST DIGOXIN TEST SYSTEM
K924504 · KXT
Diatron Corp.
Toxicology · 131d
Cleared Jan 12, 1993
ON*SITE ALCOHOL
K923337 · DML
Toxi-Lab, Inc.
Toxicology · 208d
Cleared Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
K926067 · JXM
Syva Co.
Toxicology · 42d
Cleared Jan 12, 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · DIS
Syva Co.
Toxicology · 42d
Cleared Dec 30, 1992
BARBITURATE EIA TEST
K925491 · DIS
Diagnostic Reagents, Inc.
Toxicology · 58d
Cleared Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
K924113 · DLN
Roche Diagnostic Systems, Inc.
Toxicology · 137d
Cleared Dec 28, 1992
DETECTABUSE(TM)
K925586 · DIF
Biochemical Diagnostic, Inc.
Toxicology · 54d
Cleared Dec 17, 1992
DELFIA DIGOXIN KIT
K924594 · KXT
Wallac OY
Toxicology · 98d
Cleared Dec 11, 1992
WATERS(TM) 996 PDA
K924347 · KIE
Millipore Corp.
Toxicology · 106d
Cleared Dec 11, 1992
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
K924751 · LCM
Solarcare Technologies Corp,Inc.
Toxicology · 79d
Cleared Dec 11, 1992
OPUS(R) VANCOMYCIN
K924957 · LEH
Pb Diagnostic Systems, Inc.
Toxicology · 72d
Cleared Dec 09, 1992
ETHYL ALCOHOL CALIBRATORS & CONTROL
K924733 · DNN
Diagnostic Reagents, Inc.
Toxicology · 78d
Cleared Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Nov 02, 1992
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · JXN
Syva Co.
Toxicology · 91d
Cleared Nov 02, 1992
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA
K924462 · LCM
Solarcare Technologies Corp,Inc.
Toxicology · 61d
Cleared Oct 26, 1992
BECKMAN VALPROIC ACID REAGENT
K922844 · LEG
Beckman Instruments, Inc.
Toxicology · 136d
Cleared Oct 15, 1992
OPUS(R) CK-MB
K924429 · JHY
Pb Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Oct 15, 1992
MICRO-PLATE OPIATES ASSAY
K924446 · DJG
Solarcare Technologies Corp,Inc.
Toxicology · 44d
Cleared Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
K923286 · CGN
Baxter Diagnostics, Inc.
Toxicology · 73d
Cleared Sep 15, 1992
MICRO EIA FOR OPIATE METABOLITES
K923468 · DJG
Microdiagnostics, Inc.
Toxicology · 63d
Cleared Sep 15, 1992
CEDIA DIGOXIN PLUS ASSAY
K923853 · KXT
Microgenics Corp.
Toxicology · 50d
Cleared Sep 14, 1992
THC URINE CALIBRATORS
K923386 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 75d