Device Classification Name |
System, Test, Anticardiolipin Immunological
|
510(k) Number |
K012567 |
Device Name |
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
Applicant |
CORGENIX, INC. |
12061 TEJON ST. |
WESTMINSTER,
CO
80234
|
|
Applicant Contact |
NANCI DEXTER |
Correspondent |
CORGENIX, INC. |
12061 TEJON ST. |
WESTMINSTER,
CO
80234
|
|
Correspondent Contact |
NANCI DEXTER |
Regulation Number | 866.5660
|
Classification Product Code |
|
Date Received | 08/09/2001 |
Decision Date | 08/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|