The following data is part of a premarket notification filed by Alliance International Co., Ltd. with the FDA for I-qare Ds-w Blood Glucose Monitoring System.
| Device ID | K132663 |
| 510k Number | K132663 |
| Device Name: | I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ALLIANCE INTERNATIONAL CO., LTD. NO.54 YING TAO RD. YING DISTRICT New Taipei City, 239, TW 23942 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ALLIANCE INTERNATIONAL CO., LTD. NO.54 YING TAO RD. YING DISTRICT New Taipei City, 239, TW 23942 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2015-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971292001628 | K132663 | 000 |
| 16971292006968 | K132663 | 000 |
| 16971292006975 | K132663 | 000 |
| 06971292006985 | K132663 | 000 |
| 16971292006999 | K132663 | 000 |
| 16971292007002 | K132663 | 000 |
| 16971292007019 | K132663 | 000 |
| 16971292007026 | K132663 | 000 |
| 16971292007033 | K132663 | 000 |
| 16971292001864 | K132663 | 000 |
| 16971292001611 | K132663 | 000 |
| 16971292006951 | K132663 | 000 |