The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Z2 Analyzer.
| Device ID | K991070 |
| 510k Number | K991070 |
| Device Name: | COULTER Z2 ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | COULTER CORP. 1950 WEST 8TH AVE. Hialeah, FL 33010 |
| Contact | Thomas J English |
| Correspondent | Thomas J English COULTER CORP. 1950 WEST 8TH AVE. Hialeah, FL 33010 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-05-11 |
| Summary: | summary |