Device Classification Name |
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
|
510(k) Number |
K994035 |
Device Name |
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Applicant Contact |
KAREN CALLBECK |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN,
CA
C1E 2A6
|
|
Correspondent Contact |
KAREN CALLBECK |
Regulation Number | 862.1645
|
Classification Product Code |
|
Date Received | 11/29/1999 |
Decision Date | 02/01/2000 |
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
|
|
|