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
2089–2112 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Oct 20, 1987
ACA URINE BARBITURATES SCREEN METHOD
K873623 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 42d
Cleared Oct 15, 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750 · DJR
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE
K873751 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
K873752 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · LDJ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE BARBITURATES IN URINE
K873754 · DIS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY
K873755 · DKZ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756 · LCM
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
K873757 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
K873758 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759 · KXS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 07, 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Oct 02, 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037 · DIF
Diagnostic Products Corp.
Toxicology · 59d
Cleared Oct 02, 1987
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD
K873538 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Oct 02, 1987
ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH
K873622 · DKZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 24d
Cleared Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · LAR
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Sep 22, 1987
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · KLT
Windsor Laboratories, Inc.
Toxicology · 36d
Cleared Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · LAN
Em Diagnostic Systems, Inc.
Toxicology · 33d
Cleared Sep 18, 1987
PERKIN-ELMER LC235 DIODE ARRAY DETECTOR
K872737
The Perkin-Elmer Corp.
Toxicology · 71d
Cleared Sep 14, 1987
ACA URINE DRUGS OF ABUSE CALIBRATOR
K872392 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 87d
Cleared Aug 28, 1987
IQ DIGOXIN
K864223 · KXT
Bd Becton Dickinson Vacutainer...
Toxicology · 304d
Cleared Aug 25, 1987
PROTOFLUOR Z
K871499 · JKJ
Helena Laboratories
Toxicology · 131d
Cleared Aug 21, 1987
ISO-DATA 100 SERIES GAMMA COUNTER
K872429 · JJJ
Iso-Data, Inc.
Toxicology · 60d
Cleared Aug 21, 1987
ISO-DATA 500 SERIES GAMMA COUNTER
K872430 · JJJ
Iso-Data, Inc.
Toxicology · 60d