The following data is part of a premarket notification filed by Telcare, Inc. with the FDA for Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-home Use, Telserve-professional Use.
| Device ID | K110571 |
| 510k Number | K110571 |
| Device Name: | TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TELCARE, INC. 3 BETHESDA METRO CENTER SUITE 430 Bethesda, MD 20814 |
| Contact | Jonathan C Javitt |
| Correspondent | Jonathan C Javitt TELCARE, INC. 3 BETHESDA METRO CENTER SUITE 430 Bethesda, MD 20814 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859519002247 | K110571 | 000 |
| 00859519002223 | K110571 | 000 |
| 10859519002053 | K110571 | 000 |
| 00859519002261 | K110571 | 000 |
| 00859519002391 | K110571 | 000 |