510(k) K870930

Device

Tina-quant(r) (a) C3

Applicant

BOEHRINGER MANNHEIM CORP.

510(k) number

K870930

Product code

CZM

Decision

Substantially Equivalent (SESE)

Decision date

1987-03-24

Date received

1987-03-09

Regulation

866.5510

Classification name

Iga, Ferritin, Antigen, Antiserum, Control

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Third party reviewed

N