FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Toxicology ×
3,028 results
2089–2112 of 3,028
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
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
Cleared Aug 11, 1987
ION TRAP DETECTOR (ITD)
K872464 · DOP
The Perkin-Elmer Corp.
Toxicology · 49d