The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Test, Blood Glucose System.
| Device ID | K120064 |
| 510k Number | K120064 |
| Device Name: | TEST, BLOOD GLUCOSE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HMD BIOMEDICAL, INC. NO 181, MINGSHENG ST Xinpu Township, Hsinchu County, TW 305 |
| Contact | Jessica Tung |
| Correspondent | Jessica Tung HMD BIOMEDICAL, INC. NO 181, MINGSHENG ST Xinpu Township, Hsinchu County, TW 305 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00389154000716 | K120064 | 000 |
| 04260236851128 | K120064 | 000 |
| 04260236851241 | K120064 | 000 |
| 04260236851210 | K120064 | 000 |
| 04260236851227 | K120064 | 000 |
| 04260236851180 | K120064 | 000 |
| 04260236851234 | K120064 | 000 |
| 04260236851203 | K120064 | 000 |
| 04260236851197 | K120064 | 000 |