The following data is part of a premarket notification filed by Cambridge Sensors Limited with the FDA for Microdot Xtra.
| Device ID | K083273 |
| 510k Number | K083273 |
| Device Name: | MICRODOT XTRA |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CAMBRIDGE SENSORS LIMITED UNITS 9&10 CARDINAL PARK GODMANCHESTER Huntingdon, Cambridgeshire, GB Pe29 2xg |
| Contact | Warren Reeves |
| Correspondent | Warren Reeves CAMBRIDGE SENSORS LIMITED UNITS 9&10 CARDINAL PARK GODMANCHESTER Huntingdon, Cambridgeshire, GB Pe29 2xg |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-06 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060141250530 | K083273 | 000 |
| 35060141250494 | K083273 | 000 |
| 35060141250180 | K083273 | 000 |