The following data is part of a premarket notification filed by Ok Biotech Co., Ltd. with the FDA for Prodigy Astro Blood Glucose Monitoring System, Prodigy Astro Pro Blood Glucose Monitoring System.
| Device ID | K152599 |
| 510k Number | K152599 |
| Device Name: | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | OK BIOTECH CO., LTD. NO. 91, SEC. 2, GONGDAO 5TH ROAD Hsinchu City, TW 30070 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen OK BIOTECH CO., LTD. NO. 91, SEC. 2, GONGDAO 5TH ROAD Hsinchu City, TW 30070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30384840517005 | K152599 | 000 |