BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM


Device Classification Name

reagent, borrelia serological reagent

510(k) Number K991180
Device Name BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Applicant Contact mark j kopnitsky
Correspondent
ZEUS SCIENTIFIC, INC.
200 evans way
branchburg, 
NJ 
08876

Correspodent Contact mark j kopnitsky
Regulation Number 866.3830
Classification Product Code
LSR  
Date Received 04/08/1999
Decision Date 09/03/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No