Product code DLT

Device name
Hemagglutination, Opiates
Medical specialty
Clinical Toxicology
Device class
2
Regulation number
862.3650
Review panel
TX
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
K790400URINE NEGATIVE CALIBRATORSyva Co.1979-06-15