Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K123725 |
Device Name |
FASTPACK CONTROL KIT |
Applicant |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
Michael Poirier |
Correspondent |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
Michael Poirier |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/04/2012 |
Decision Date | 03/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|