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
1537–1560 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 08, 1993
ACETASITE
K931257 · LDP
Gds Diagnostics
Toxicology · 118d
Cleared Jul 08, 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · DIF
Bio-Rad
Toxicology · 36d
Cleared Jun 29, 1993
CANNABINOID URINE CONTROLS
K932113 · JJX
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Jun 16, 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · JLW
Bio-Rad
Toxicology · 107d
Cleared Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · DKC
Sigma Diagnostics, Inc.
Toxicology · 48d
Cleared Jun 15, 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · DIS
Syva Co.
Toxicology · 78d
Cleared Jun 15, 1993
USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
K932318 · DJG
U.S. Drug Testing, Inc.
Toxicology · 35d
Cleared Jun 07, 1993
ACS DIGOXIN IMMUNOASSAY
K931213 · KXT
Ciba Corning Diagnostics Corp.
Toxicology · 89d
Cleared May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598 · LDJ
Biosite Incorporated
Toxicology · 41d
Cleared May 11, 1993
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · JJW
Heraeus Kulzer, Inc.
Toxicology · 48d
Cleared May 11, 1993
EMIT(R) D.A.U. BENZODIAZEPINE ASSAY
K931536 · JXM
Syva Co.
Toxicology · 43d
Cleared May 06, 1993
ABBOTT VISION THEOPHYLLINE IIA
K926245 · KLS
Abbott Laboratories
Toxicology · 143d
Cleared May 06, 1993
STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA
K930654 · LDJ
Solarcare Technologies Corp,Inc.
Toxicology · 86d
Cleared May 06, 1993
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
K931227 · KZR
U.S. Drug Testing, Inc.
Toxicology · 57d
Cleared Apr 27, 1993
USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100
K930985 · DIO
U.S. Drug Testing, Inc.
Toxicology · 61d
Cleared Apr 21, 1993
PROCHECK(TM) BLIND PERFORMANCE SPECIMENS
K931105 · DIF
Dynagen, Inc.
Toxicology · 49d
Cleared Apr 20, 1993
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
K930208 · DLI
Heraeus Kulzer, Inc.
Toxicology · 95d
Cleared Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
K930845 · DIW
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Apr 16, 1993
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
K930690 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 65d
Cleared Mar 10, 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 56d
Cleared Feb 25, 1993
COBAS-FP TDM CONTROLS
K930269 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Jan 27, 1993
ACCESS(R) FREE T4 ASSAY
K925913 · CEC
Bio-Rad Laboratories, Inc.
Toxicology · 65d
Cleared Jan 26, 1993
MICROPLATE CANNABINOIDS ASSAY
K924815 · LDJ
Solarcare Technologies Corp,Inc.
Toxicology · 123d
Cleared Jan 26, 1993
MAXSOFTWARE
K925547 · JQW
Diagnostic Products Corp.
Toxicology · 84d