Device Classification Name |
System, Test, Infectious Mononucleosis
|
510(k) Number |
K042272 |
Device Name |
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) |
Applicant |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EDWARD TUNG, PH.D. |
Correspondent |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
EDWARD TUNG, PH.D. |
Regulation Number | 866.5640
|
Classification Product Code |
|
Date Received | 08/23/2004 |
Decision Date | 02/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|