The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Act Tron Cell Control.
| Device ID | K971469 |
| 510k Number | K971469 |
| Device Name: | COULTER ACT TRON CELL CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Thomas J English |
| Correspondent | Thomas J English COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-22 |
| Decision Date | 1997-06-30 |
| Summary: | summary |