510(k) K871027

Device

Precinorm(r) Protein

Applicant

BOEHRINGER MANNHEIM CORP.

510(k) number

K871027

Product code

DAF

Decision

Substantially Equivalent (SESE)

Decision date

1987-05-15

Date received

1987-03-16

Regulation

866.5510

Classification name

Gamma Globulin, Fitc, Antigen, Antiserum, Control

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Third party reviewed

N