Device Classification Name |
indicator method, protein or albumin (urinary, non-quant.)
|
510(k) Number |
K991315 |
Device Name |
MICROALBUSTIX REAGENT STRIPS (OTC) |
Applicant |
BAYER CORP. |
1884 MILES AVE. |
ELKHART,
IN
46514
|
|
Applicant Contact |
GEORGE M TANCOS |
Correspondent |
BAYER CORP. |
1884 MILES AVE. |
ELKHART,
IN
46514
|
|
Correspondent Contact |
GEORGE M TANCOS |
Regulation Number | 862.1645
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/19/1999 |
Decision Date | 11/12/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|