Device Classification Name |
mixture, hematology quality control
|
510(k) Number |
K010598 |
Device Name |
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL |
Applicant |
QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. |
REDONDO BEACH,
CA
90278 -1205
|
|
Applicant Contact |
EVA LASZLO |
Correspondent |
QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. |
REDONDO BEACH,
CA
90278 -1205
|
|
Correspondent Contact |
EVA LASZLO |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 02/28/2001 |
Decision Date | 03/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|