COBAS 4800 CT / NG TEST


Device Classification Name

dna probe, nucleic acid amplification, chlamydia

510(k) Number K110923
Device Name COBAS 4800 CT / NG TEST
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton, 
CA 
94588 -2722

Applicant Contact james bonds
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton, 
CA 
94588 -2722

Correspodent Contact james bonds
Regulation Number 866.3120
Classification Product Code
MKZ  
Subsequent Product Codes
LSL   OOI  
Date Received 04/01/2011
Decision Date 01/24/2012
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