The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Precichek Ns-101 Poct Professional Blood Glucose Monitoring System.
| Device ID | K113314 |
| 510k Number | K113314 |
| Device Name: | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, TW 30542 |
| Contact | Wang Yunhan |
| Correspondent | Wang Yunhan HMD BIOMEDICAL, INC. #181 MINSHENG STREET Xinpu Township, TW 30542 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-09 |
| Decision Date | 2012-11-09 |
| Summary: | summary |