The following data is part of a premarket notification filed by Nanoentek, Inc. with the FDA for Automated Differential Cell Counter.
| Device ID | BK180283 |
| 510k Number | BK180283 |
| Device Name: | Automated Differential Cell Counter |
| Classification | Counter, Differential Cell |
| Applicant | Nanoentek, Inc. 12f, 5, Digital-ro 26-gil Guro-gu Seoul, 152-740, KS |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317540634 | BK180283 | 0 |
| 08809317540627 | BK180283 | 0 |