VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)


Device Classification Name

system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen

510(k) Number K112424
Device Name VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
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 866.1640
Classification Product Code
NQX  
Subsequent Product Code
NSU  
Date Received 08/23/2011
Decision Date 12/16/2011
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