The following data is part of a premarket notification filed by Cambridge Sensors Limited with the FDA for Microdot & Microdot Xtra.
| Device ID | K102383 |
| 510k Number | K102383 |
| Device Name: | MICRODOT & 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 | Bernadette Yon-hin |
| Correspondent | Bernadette Yon-hin CAMBRIDGE SENSORS LIMITED UNITS 9&10 CARDINAL PARK GODMANCHESTER Huntingdon, Cambridgeshire, GB Pe29 2xg |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-23 |
| Decision Date | 2012-01-27 |
| Summary: | summary |