The following data is part of a premarket notification filed by Nanoentek, Inc. with the FDA for Test, Residual, Wbc In Leukoreduced Blood.
| Device ID | BK210621 |
| 510k Number | BK210621 |
| Device Name: | Test, Residual, WBC In Leukoreduced Blood |
| Classification | Test, Residual, Wbc In Leukoreduced Blood |
| Applicant | Nanoentek, Inc. nanoentek, Inc. 851-14 Seohae-ro, Paltan-myeon 09 Hwaseong-si, 18531, KOREA, SOUTH |
| Product Code | MZG |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317541143 | BK210621 | 0 |