Device Classification Name |
method, enzymatic, glucose (urinary, non-quantitative)
|
510(k) Number |
K060280 |
Device Name |
ICHEM 100 URINE CHEMISTRY ANALYZER |
Applicant |
IRIS INTERNATIONAL, INC. |
9172 ETON AVE. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
GERALD J HADDOCK |
Correspondent |
IRIS INTERNATIONAL, INC. |
9172 ETON AVE. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
GERALD J HADDOCK |
Regulation Number | 862.1340
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/02/2006 |
Decision Date | 06/13/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|