The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Hematology Analyzers With Irf & Mrv Analyses.
| Device ID | K993356 |
| 510k Number | K993356 |
| Device Name: | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Contact | Stan Sugrue |
| Correspondent | Stan Sugrue COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-06 |
| Decision Date | 2000-04-20 |
| Summary: | summary |