ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT


Device Classification Name

dna probe, nucleic acid amplification, chlamydia

510(k) Number K080739
Device Name ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, 
IL 
60018

Applicant Contact paula e martin
Correspondent
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, 
IL 
60018

Correspodent Contact paula e martin
Regulation Number 866.3120
Classification Product Code
MKZ  
Subsequent Product Code
LSL  
Date Received 03/17/2008
Decision Date 07/10/2008
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