Device Classification Name |
counter, urine particle
|
510(k) Number |
K022774 |
Device Name |
IQ 200 SYSTEM |
Applicant |
INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
HARVEY L KASDAN |
Correspondent |
INTL. REMOTE IMAGING SYSTEMS |
9162 ETON AVE. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
HARVEY L KASDAN |
Regulation Number | 864.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/21/2002 |
Decision Date | 10/21/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|