Product code CZM

Device name
Iga, Ferritin, Antigen, Antiserum, Control
Medical specialty
Immunology
Device class
2
Regulation number
866.5510
Review panel
IM
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
K870930TINA-QUANT(R) (A) C3Boehringer Mannheim Corp.1987-03-24