Device Classification Name |
legionella, spp., elisa
|
510(k) Number |
K070522 |
Device Name |
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 |
Applicant |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS |
10 SOUTHGATE RD. |
SCARBOROUGH,
ME
04074
|
|
Applicant Contact |
KAREN MORTIMER |
Correspondent |
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS |
10 SOUTHGATE RD. |
SCARBOROUGH,
ME
04074
|
|
Correspondent Contact |
KAREN MORTIMER |
Regulation Number | 866.3300
|
Classification Product Code |
|
Date Received | 02/23/2007 |
Decision Date | 03/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|