IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG


Device Classification Name

helicobacter pylori

510(k) Number K000463
Device Name IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles, 
CA 
90045 -5597

Original Contact edward m levine
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 02/11/2000
Decision Date 06/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized