Device Classification Name |
urinalysis controls (assayed and unassayed)
|
510(k) Number |
K945913 |
Device Name |
IRISPEC URINE CHEMISTRY CONTROL PART A AND B |
Applicant |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
9825 DE SOTO AVE. |
CHARTSWORTH,
CA
91311
|
|
Applicant Contact |
SANFORD WIDRAN |
Correspondent |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
9825 DE SOTO AVE. |
CHARTSWORTH,
CA
91311
|
|
Correspondent Contact |
SANFORD WIDRAN |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/02/1994 |
Decision Date | 04/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|