Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K983952 |
Device Name |
GREINER VACUETTE BLOOD COLLECTION TUBE |
Applicant |
GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A |
BEL AIR,
MD
21014
|
|
Applicant Contact |
DOUG HARRIS |
Correspondent |
GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A |
BEL AIR,
MD
21014
|
|
Correspondent Contact |
DOUG HARRIS |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 11/05/1998 |
Decision Date | 12/28/1998 |
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
|
|
|