QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024


Device Classification Name

reagent, borrelia serological reagent

510(k) Number K991062
Device Name QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
Applicant
IMMUNETICS, INC.
63 rogers st.
cambridge,, 
MA 
02142

Applicant Contact andrew e levin
Correspondent
IMMUNETICS, INC.
63 rogers st.
cambridge,, 
MA 
02142

Correspodent Contact andrew e levin
Regulation Number 866.3830
Classification Product Code
LSR  
Date Received 03/31/1999
Decision Date 09/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No