Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K150052 |
Device Name |
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System |
Applicant |
Nipro Diagnostics, Inc |
2400 NW 55th Court |
Fort Lauderdale,
FL
33309
|
|
Applicant Contact |
Simeon Simone |
Correspondent |
Nipro Diagnostics, Inc |
2400 NW 55th Court |
Fort Lauderdale,
FL
33309
|
|
Correspondent Contact |
Simeon Simone |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 01/12/2015 |
Decision Date | 03/26/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|