The following data is part of a premarket notification filed by Philosys Co. Ltd. with the FDA for Blood Glucose Monitoring System (glucose Oxidase).
| Device ID | K113636 |
| 510k Number | K113636 |
| Device Name: | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | PHILOSYS CO. LTD. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 |
| Contact | Linda Chan |
| Correspondent | Linda Chan PHILOSYS CO. LTD 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-09 |
| Decision Date | 2013-03-08 |
| Summary: | summary |