Device Classification Name |
indicator method, protein or albumin (urinary, non-quant.)
|
510(k) Number |
K972337 |
Device Name |
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Applicant Contact |
KAREN CALLBECK |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Correspondent Contact |
KAREN CALLBECK |
Regulation Number | 862.1645
|
Classification Product Code |
|
Date Received | 06/23/1997 |
Decision Date | 08/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|