510(k) K831055

Device

Hemoglobin Electrophoresis Meth On The-

Applicant

OLYMPUS CORP.

510(k) number

K831055

Product code

JBO

Decision

Substantially Equivalent (SESE)

Decision date

1983-06-08

Date received

1983-04-01

Regulation

864.7275

Classification name

Test, Euglobulin Lysis

Medical specialty

Hematology

Review panel

Hematology

Device class

2

Clearance type

Traditional

Third party reviewed

N