The following data is part of a premarket notification filed by Agamatrix Inc with the FDA for Liberty Blood Glucose Monitoring System, Model 8000-0067.
Device ID | K052762 |
510k Number | K052762 |
Device Name: | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | AGAMATRIX INC 230 ALBANY STREET Cambridge, MA 02139 |
Contact | Connie Hertel |
Correspondent | Connie Hertel AGAMATRIX INC 230 ALBANY STREET Cambridge, MA 02139 |
Product Code | NBW |
Subsequent Product Code | CGA |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-30 |
Decision Date | 2006-01-23 |
Summary: | summary |