Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K935833 |
Device Name |
LCX NEISSERIA GONORRHOEAE ASSAY |
Applicant |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
MARY SPIEWAK |
Correspondent |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
MARY SPIEWAK |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 12/07/1993 |
Decision Date | 05/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|