ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)


Device Classification Name

antinuclear antibody, antigen, control

510(k) Number K021257
Device Name ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact edward m levine
Regulation Number 866.5100
Classification Product Code
LKJ  
Date Received 04/19/2002
Decision Date 06/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No