The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Glocyte Automated Cell Counter System.
| Device ID | K152776 |
| 510k Number | K152776 |
| Device Name: | Glocyte Automated Cell Counter System |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | Advanced Instruments, Inc. 2 Technology Way Norwood, MA 02062 |
| Contact | Robert Mello |
| Correspondent | Robert Mello Advanced Instruments, Inc. 2 Technology Way Norwood, MA 02062 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816068020245 | K152776 | 000 |
| 00816068020238 | K152776 | 000 |
| 00816068020191 | K152776 | 000 |
| 00816068020184 | K152776 | 000 |
| 00816068020153 | K152776 | 000 |
| 00816068020146 | K152776 | 000 |
| 00816068020016 | K152776 | 000 |
| 00816068020009 | K152776 | 000 |
| 20816068020201 | K152776 | 000 |