The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-check Compact Plus Blood Glucose Monitoring System.
| Device ID | K113614 |
| 510k Number | K113614 |
| Device Name: | ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Contact | Michael Flis |
| Correspondent | Michael Flis Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-06 |
| Decision Date | 2013-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702468108 | K113614 | 000 |
| 10365702192109 | K113614 | 000 |
| 00075537927144 | K113614 | 000 |
| 00075537598849 | K113614 | 000 |
| 00075537546611 | K113614 | 000 |
| 00075537474198 | K113614 | 000 |