Device Classification Name |
station, pipetting and diluting, for clinical use
|
510(k) Number |
K953345 |
Device Name |
GENESIS |
Applicant |
TECAN U.S., INC. |
P.O. BOX 13953 |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
DAVID L JURANAS |
Correspondent |
TECAN U.S., INC. |
P.O. BOX 13953 |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
DAVID L JURANAS |
Regulation Number | 862.2750
|
Classification Product Code |
|
Date Received | 07/12/1995 |
Decision Date | 11/21/1995 |
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
|
|
|