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
1681–1704 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 30, 1991
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · KLT
Syva Co.
Toxicology · 20d
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · LFW
Microgenics Corp.
Toxicology · 72d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 22, 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729 · DKB
Syva Co.
Toxicology · 32d
Cleared Jul 05, 1991
INNOFLUOR(TM) VALPROIC ACID REAGENT SET
K911688 · LEG
Intl. Bioclinical, Inc.
Toxicology · 80d
Cleared Jul 01, 1991
OPUS(R) TOBRAMYCIN
K911940 · LCR
Pb Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jun 28, 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · LCR
Exmoor Plastics , Ltd.
Toxicology · 86d
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 129d
Cleared Jun 18, 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153 · LCM
Immunotech Corp.
Toxicology · 95d
Cleared Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725 · LCM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared May 23, 1991
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
K911954 · DJR
Bio-Rad
Toxicology · 22d
Cleared May 22, 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 35d
Cleared May 15, 1991
MIRCOLINE SCREEN FOR COCAINE
K911652 · DIO
Drug Screening Systems, Inc.
Toxicology · 33d
Cleared May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941 · KXT
Microgenics Corp.
Toxicology · 14d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
K911170 · JIY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
K911177 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d