PLATELIA LYME IGM


Device Classification Name

reagent, borrelia serological reagent

510(k) Number K081362
Device Name PLATELIA LYME IGM
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 05/15/2008
Decision Date 06/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No