PLATELIA LYME IGG ASSAY


Device Classification Name

reagent, borrelia serological reagent

510(k) Number K080012
Device Name PLATELIA LYME IGG ASSAY
Applicant
BIO-RAD
163 cabot st.
beverly, 
MA 
01915

Applicant Contact fran white
Correspondent
BIO-RAD
163 cabot st.
beverly, 
MA 
01915

Correspodent Contact fran white
Regulation Number 866.3830
Classification Product Code
LSR  
Date Received 01/03/2008
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No