The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Bioland Blood Glucose Monitoring System.
| Device ID | K191657 |
| 510k Number | K191657 |
| Device Name: | Bioland Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong Road Baolong Community, Longgang District, Sh, CN 518116 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Baolong Community, Longgang District, Sh, CN 518116 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2020-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16939184630073 | K191657 | 000 |
| 16939184600359 | K191657 | 000 |
| 16939184630479 | K191657 | 000 |
| 00810143550153 | K191657 | 000 |
| 06939184600901 | K191657 | 000 |
| 06939184600918 | K191657 | 000 |
| 06939184600925 | K191657 | 000 |
| 16939184600939 | K191657 | 000 |
| 16939184630233 | K191657 | 000 |
| 16939184627103 | K191657 | 000 |
| 04897100310070 | K191657 | 000 |
| 06939184600192 | K191657 | 000 |
| 06939184630090 | K191657 | 000 |
| 00860005561704 | K191657 | 000 |
| 00863398000294 | K191657 | 000 |
| 16934440100000 | K191657 | 000 |
| 16934440100017 | K191657 | 000 |
| 06939184600178 | K191657 | 000 |
| 00850070979054 | K191657 | 000 |