BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST


Device Classification Name

legionella, spp., elisa

510(k) Number K991074
Device Name BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
Applicant
INTRACEL CORP.
1330 piccard dr.
rockville, 
MD 
20850

Applicant Contact sheryl ruppel
Correspondent
INTRACEL CORP.
1330 piccard dr.
rockville, 
MD 
20850

Correspodent Contact sheryl ruppel
Regulation Number 866.3300
Classification Product Code
MJH  
Date Received 03/31/1999
Decision Date 12/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No