The following data is part of a premarket notification filed by Tianjin New Bay Bioresearch Co., Ltd. with the FDA for Glucose Pilot.
| Device ID | K052208 |
| 510k Number | K052208 |
| Device Name: | GLUCOSE PILOT |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Contact | Rodbrigo Berlie |
| Correspondent | Rodbrigo Berlie Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA Carlsbad, CA 92009 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-12 |
| Decision Date | 2005-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850632007383 | K052208 | 000 |
| 10850632007376 | K052208 | 000 |
| 10850632007369 | K052208 | 000 |
| 00748349000717 | K052208 | 000 |
| 00383568100802 | K052208 | 000 |
| 00383568100826 | K052208 | 000 |