XPERT CT/NG


Device Classification Name

dna-reagents, neisseria

510(k) Number K121710
Device Name XPERT CT/NG
Applicant
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089

Applicant Contact russel k enns
Correspondent
CEPHEID
904 caribbean drive
sunnyvale, 
CA 
94089

Correspodent Contact russel k enns
Regulation Number 866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   OOI  
Date Received 06/11/2012
Decision Date 12/27/2012
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