Device Classification Name |
enzyme immunoassay, phencyclidine
|
510(k) Number |
K043071 |
Device Name |
RANDOX PHENCYCLIDINE ASSAY |
Applicant |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
P. ARMSTRONG |
Correspondent |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
P. ARMSTRONG |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/08/2004 |
Decision Date | 01/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|