510(k) K043341

Device

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

Applicant

BIO-RAD LABORATORIES, INC.

510(k) number

K043341

Product code

NVI  

Decision

Substantially Equivalent (SESE)

Decision date

2005-10-27

Date received

2004-12-03

Regulation

862.3100

Classification name

Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease

Medical specialty

Toxicology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No