VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST


Device Classification Name

gram-positive bacteria and their resistance markers

510(k) Number K122514
Device Name VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
Applicant
NANOSPHERE, INC
4088 commercial avenue
northbrook, 
IL 
60062

Applicant Contact mark del vecchio
Correspondent
NANOSPHERE, INC
4088 commercial avenue
northbrook, 
IL 
60062

Correspodent Contact mark del vecchio
Regulation Number 866.3365
Classification Product Code
PAM  
Date Received 08/17/2012
Decision Date 09/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls