510(k) K900107

Device

Ld-1

Applicant

BOEHRINGER MANNHEIM CORP.

510(k) number

K900107

Product code

DET

Decision

Substantially Equivalent (SESE)

Decision date

1990-01-18

Date received

1990-01-09

Regulation

866.5560

Classification name

Lactic Dehydrogenase, Antigen, Antiserum, Control

Medical specialty

Immunology

Review panel

Immunology

Device class

1

Clearance type

Traditional

Third party reviewed

N