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 |