The following data is part of a premarket notification filed by Coulter Corp. with the FDA for 4c Plus Coulter Cell Control.
| Device ID | K955016 |
| 510k Number | K955016 |
| Device Name: | 4C PLUS COULTER CELL CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Benita Bourque |
| Correspondent | Benita Bourque 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 | 1995-11-02 |
| Decision Date | 1996-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590230302 | K955016 | 000 |
| 15099590225216 | K955016 | 000 |