Device Classification Name |
system, test, anticardiolipin immunological
|
510(k) Number |
K933588 |
Device Name |
APHLELISA KIT |
Applicant |
LOUISVILLE APL DIAGNOSTICS, INC. |
2311 FALLSVIEW RD. |
PO BOX 728 |
LOUISVILLE,
KY
40201
|
|
Applicant Contact |
E. NIGEL HARRIS |
Correspondent |
LOUISVILLE APL DIAGNOSTICS, INC. |
2311 FALLSVIEW RD. |
PO BOX 728 |
LOUISVILLE,
KY
40201
|
|
Correspondent Contact |
E. NIGEL HARRIS |
Regulation Number | 866.5660
|
Classification Product Code |
|
Date Received | 07/26/1993 |
Decision Date | 10/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|