XPERT MRSA/SA SSTI ASSAY


Device Classification Name

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

510(k) Number K080837
Device Name XPERT MRSA/SA SSTI ASSAY
Applicant
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Applicant Contact russel k ennis
Correspondent
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089 -1189

Correspodent Contact russel k ennis
Regulation Number 866.1640
Classification Product Code
NQX  
Date Received 03/25/2008
Decision Date 09/24/2008
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