FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Substantially Equivalent 510(k) Device Information

horizontal rule

Applicant: Biometric Imaging, Inc. Mountain View, CA
510(k) number: BK970015
Product: CEQer RBC Assay
Date: 9/18/98

horizontal rule

Letter

Statement (PDF), (Text)

 

 
horizontal rule