The following data is part of a premarket notification filed by Arkray Factory, Inc. with the FDA for Glucocard W Blood Glucose Monitoring System.
| Device ID | K170064 |
| 510k Number | K170064 |
| Device Name: | GLUCOCARD W Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ARKRAY FACTORY, INC. 1480 KOJI, KONAN-CHO Koka-shi, JP 520-3306 |
| Contact | Kazuya Yorimitsu |
| Correspondent | Wendy Kivens ARKRAY AMERICA, INC. 5182 WEST 76TH STREET Edina, MN 55439 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20015482512051 | K170064 | 000 |
| 10015482511101 | K170064 | 000 |
| 00015482510077 | K170064 | 000 |
| 00015482510053 | K170064 | 000 |
| 00015482510046 | K170064 | 000 |