Device Classification Name |
dna probe, nucleic acid amplification, chlamydia
|
510(k) Number |
K934622 |
Device Name |
LCX CHLAMYDIA TRACHOMATIS ASSAY |
Applicant |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
MATT KLAMRZYNSKI |
Correspondent |
ABBOTT LABORATORIES |
DEPT: 09V8 BLDG: AP5-2 |
100 ABBOTT PARK ROAD |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
MATT KLAMRZYNSKI |
Regulation Number | 866.3120
|
Classification Product Code |
|
Date Received | 09/27/1993 |
Decision Date | 12/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|