The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Series 9100 Plus Automated Differential Hematology Analyzers.
| Device ID | K953598 |
| 510k Number | K953598 |
| Device Name: | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS |
| Classification | Counter, Differential Cell |
| Applicant | SERONO DIAGNOSTICS, INC. 555 13TH STREET, N.W. Washington, DC 20004 -5910 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein SERONO DIAGNOSTICS, INC. 555 13TH STREET, N.W. Washington, DC 20004 -5910 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-01 |
| Decision Date | 1996-03-11 |
| Summary: | summary |