The following data is part of a premarket notification filed by Nanoentek, Inc. with the FDA for Automated Differential Cell Counter.
| Device ID | BK120068 |
| 510k Number | BK120068 |
| Device Name: | Automated Differential Cell Counter |
| Classification | Counter, Differential Cell |
| Applicant | Nanoentek, Inc. 300 Washington St., Ste 416 Newton, MA 02458 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2012-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317540504 | BK120068 | 0 |
| 08809317540498 | BK120068 | 0 |
| 08809317540252 | BK120068 | 0 |