Device Classification Name |
diazo (colorimetric), nitrite (urinary, non-quant)
|
510(k) Number |
K993850 |
Device Name |
URINALYSIS REAGENT STRIPS (10 PARAMETERS) |
Applicant |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
1629 FOSTERS WAY |
DELTA, BRITISH COLUMBIA,
CA
V3M 6S7
|
|
Applicant Contact |
DENNIS S.L. HONG |
Correspondent |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
1629 FOSTERS WAY |
DELTA, BRITISH COLUMBIA,
CA
V3M 6S7
|
|
Correspondent Contact |
DENNIS S.L. HONG |
Regulation Number | 862.1510
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/12/1999 |
Decision Date | 01/03/2000 |
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
|
Recalls |
CDRH Recalls
|
|
|