Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K960857 |
Device Name |
GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR |
Applicant |
GREINER AMERICA, INC. |
7 HENRY CT. |
WILMINGTON,
DE
19808
|
|
Applicant Contact |
ED MAIER |
Correspondent |
GREINER AMERICA, INC. |
7 HENRY CT. |
WILMINGTON,
DE
19808
|
|
Correspondent Contact |
ED MAIER |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 03/01/1996 |
Decision Date | 08/30/1996 |
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
|
|
|