| Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device |
| 510(K) Number |
K021941 |
| Device Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant |
ITL CORPORATION, PTY LTD.
41-45 TENNANT ST.
FYSHWICK, CANBERRA ACT 2609 AU
Other 510(k) Applications for this Company
|
| Contact |
WILIAM L MOBBS
Other 510(k) Applications for this Contact |
| Regulation Number |
862.1675
More FDA Info for this Regulation Number |
| Classification Product Code |
JKA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
06/13/2002 |
| Decision Date |
07/02/2002 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CH - Clinical Chemistry |
| Review Advisory Committee |
CH - Clinical Chemistry |
| Statement / Summary / Purged Status |
Summary |
| Type |
Special |
| Reviewed By Third Party |
N |
| Expedited Review |
|