The following data is part of a premarket notification filed by Cea America Corp. with the FDA for Medicount Deka Hematology Analyzer.
| Device ID | K942525 |
| 510k Number | K942525 |
| Device Name: | MEDICOUNT DEKA HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | CEA AMERICA CORP. 5300 MEMORIAL DR. #310 Houston, TX 77007 |
| Contact | Thomas Burtnett |
| Correspondent | Thomas Burtnett CEA AMERICA CORP. 5300 MEMORIAL DR. #310 Houston, TX 77007 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1996-06-05 |