The following data is part of a premarket notification filed by Technalysis, Inc. with the FDA for Cellexis Hematology Analyzer.
| Device ID | K923773 |
| 510k Number | K923773 |
| Device Name: | CELLEXIS HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | TECHNALYSIS, INC. 1805 RUTHERFORD LN. Austin, TX 78754 |
| Contact | Stephen C Biby |
| Correspondent | Stephen C Biby TECHNALYSIS, INC. 1805 RUTHERFORD LN. Austin, TX 78754 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-24 |
| Decision Date | 1993-02-05 |