510(k) K952817

Device

Bio-rad Urinary 5-hiaa By Hplc

Applicant

BIO-RAD

510(k) number

K952817

Product code

CDA

Decision

Substantially Equivalent (SESE)

Decision date

1995-08-01

Date received

1995-06-20

Regulation

862.1390

Classification name

Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

Medical specialty

Clinical Chemistry

Review panel

Clinical Chemistry

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No