Device Classification Name |
dye-indicator, ph (urinary, non-quantitative)
|
510(k) Number |
K051727 |
Device Name |
AIMSTICK URINE REAGENT STRIPS |
Applicant |
GERMAINE LABORATORIES, INC. |
4139 GARDENDALE CENTER, |
SUITE 101 |
SAN ANTONIO,
TX
78229
|
|
Applicant Contact |
MARTIN O'CONNOR |
Correspondent |
GERMAINE LABORATORIES, INC. |
4139 GARDENDALE CENTER, |
SUITE 101 |
SAN ANTONIO,
TX
78229
|
|
Correspondent Contact |
MARTIN O'CONNOR |
Regulation Number | 862.1550
|
Classification Product Code |
|
Date Received | 06/28/2005 |
Decision Date | 10/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|