Device Classification Name |
system, test, vitamin d
|
510(k) Number |
K123983 |
Device Name |
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS |
Applicant |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
SUITE B |
CARLSBAD,
CA
92011 -1438
|
|
Applicant Contact |
MICHAEL S POIRIER |
Correspondent |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
SUITE B |
CARLSBAD,
CA
92011 -1438
|
|
Correspondent Contact |
MICHAEL S POIRIER |
Regulation Number | 862.1825
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/26/2012 |
Decision Date | 07/03/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|