The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Flow-count Coulter Fluorospheres.
| Device ID | K954688 |
| 510k Number | K954688 |
| Device Name: | FLOW-COUNT COULTER FLUOROSPHERES |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide COULTER CORP. 11800 S.W. 147TH AVE. 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 | 1995-10-11 |
| Decision Date | 1996-02-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590542450 | K954688 | 000 |
| 15099590390471 | K954688 | 000 |