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
1801–1824 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 26, 1990
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · LEG
Pb Diagnostic Systems, Inc.
Toxicology · 85d
Cleared Jun 26, 1990
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · KXT
Pb Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Jun 26, 1990
OPUS (TM) HCG
K901935 · JHI
Pb Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Jun 20, 1990
PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
K901531 · DNP
Pioneering Technologies, Inc.
Toxicology · 90d
Cleared Jun 12, 1990
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · KLS
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 74d
Cleared Jun 12, 1990
MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
K901537 · LET
Pb Diagnostic Systems, Inc.
Toxicology · 71d
Cleared Jun 06, 1990
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
K901573 · DKB
Syva Co.
Toxicology · 63d
Cleared Jun 01, 1990
SPEC(TM) EXTRACTION CARTRIDGE
K901694 · DKE
Toxi-Lab, Inc.
Toxicology · 52d
Cleared May 31, 1990
ENZYMUN TEST(R) DIGOXIN
K901216 · KXT
Boehringer Mannheim Corp.
Toxicology · 78d
Cleared May 30, 1990
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
K900373 · KLS
Biotrack, Inc.
Toxicology · 124d
Cleared May 17, 1990
MILENIA(TM) CANNABINOIDS
K901568 · LDJ
Diagnostic Products Corp.
Toxicology · 43d
Cleared May 17, 1990
MILENIA(TM) OPIATES
K901577 · DJG
Diagnostic Products Corp.
Toxicology · 43d
Cleared May 14, 1990
HYCOR ACCUPINCH THC TEST
K901334 · LDJ
Hycor Biomedical, Inc.
Toxicology · 53d
Cleared May 10, 1990
SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM
K897118 · LDP
Medisense, Inc.
Toxicology · 135d
Cleared May 02, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · DIF
Bio-Rad
Toxicology · 44d
Cleared Apr 26, 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921 · LCM
Hycor Biomedical, Inc.
Toxicology · 58d
Cleared Apr 26, 1990
HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL
K901276 · DIT
Diagnostic Products Corp.
Toxicology · 38d
Cleared Apr 25, 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · LCM
Abbott Laboratories
Toxicology · 56d
Cleared Apr 20, 1990
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707 · LFW
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Apr 20, 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995 · DKZ
Syva Co.
Toxicology · 50d
Cleared Apr 19, 1990
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
K900708 · LEH
Innotron of Oregon, Inc.
Toxicology · 66d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
K900702 · LGI
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
K900703 · LCD
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · LGQ
Innotron of Oregon, Inc.
Toxicology · 59d