The following data is part of a premarket notification filed by Hamilton Thorne Research with the FDA for Ivos Analyzer.
| Device ID | K920719 |
| 510k Number | K920719 |
| Device Name: | IVOS ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | HAMILTON THORNE RESEARCH 181 ELLIOTT ST. 100 CUMMINGS CENTER-SUITE 102C Beverly, MA 01915 -6101 |
| Contact | Douglas-hamilton |
| Correspondent | Douglas-hamilton HAMILTON THORNE RESEARCH 181 ELLIOTT ST. 100 CUMMINGS CENTER-SUITE 102C Beverly, MA 01915 -6101 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858604006719 | K920719 | 000 |
| 00858604006108 | K920719 | 000 |