The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Positive Control Cells.
| Device ID | K894651 |
| 510k Number | K894651 |
| Device Name: | COULTER POSITIVE CONTROL CELLS |
| Classification | Control, White-cell |
| Applicant | COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Contact | Gregory Butchko |
| Correspondent | Gregory Butchko COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Product Code | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590541972 | K894651 | 000 |