Device Classification Name |
Tubes, Vacuum Sample, With Anticoagulant
|
510(k) Number |
K971221 |
Device Name |
GREINER VACUETTE BLOOD COLLECTION TUBE |
Applicant |
GREINER AMERICA, INC. |
P.O. BOX 953279 |
LAKE MARY,
FL
32795 -3279
|
|
Applicant Contact |
ED MAIER |
Correspondent |
GREINER AMERICA, INC. |
P.O. BOX 953279 |
LAKE MARY,
FL
32795 -3279
|
|
Correspondent Contact |
ED MAIER |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 04/02/1997 |
Decision Date | 05/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|