Self-contained Blood Grouping Device
Self-contained Blood Grouping
Micronics
The following data is part of a premarket notification filed by Micronics with the FDA for Self-contained Blood Grouping Device.
Pre-market Notification Details
| Device ID | BK100008 |
| 510k Number | BK100008 |
| Device Name: | Self-contained Blood Grouping Device |
| Classification | Self-contained Blood Grouping |
| Applicant | Micronics 8463 154th Avenue Ne Redmond, WA 98052 |
| Product Code | OQX |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-18 |
| Decision Date | 2010-04-30 |
NIH GUDID Devices
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