The following data is part of a premarket notification filed by Cambridge Sensors Limited with the FDA for Microdot Blood Glucose Monitoring System.
| Device ID | K070524 |
| 510k Number | K070524 |
| Device Name: | MICRODOT BLOOD GLUCOSE MONITORING SYSTEM |
| 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 | 2007-02-23 |
| Decision Date | 2007-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060141250554 | K070524 | 000 |
| 05060141250592 | K070524 | 000 |