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 |
16971292006951 | K132663 | 000 |
16971292003226 | K132663 | 000 |
16971292003196 | K132663 | 000 |
16971292003189 | K132663 | 000 |
16971292003172 | K132663 | 000 |
16971292003165 | K132663 | 000 |
16971292003158 | K132663 | 000 |
16971292003141 | K132663 | 000 |
16971292006968 | K132663 | 000 |
16971292006975 | K132663 | 000 |
16971292001611 | K132663 | 000 |
16971292001864 | K132663 | 000 |
16971292007033 | K132663 | 000 |
16971292007026 | K132663 | 000 |
16971292007019 | K132663 | 000 |
16971292007002 | K132663 | 000 |
16971292006999 | K132663 | 000 |
06971292006985 | K132663 | 000 |
16971292003134 | K132663 | 000 |