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 |