The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Multi Q Prep.
| Device ID | K935953 |
| 510k Number | K935953 |
| Device Name: | COULTER MULTI Q PREP |
| Classification | Apparatus, Automated Blood Cell Diluting |
| Applicant | COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Contact | Thomas English |
| Correspondent | Thomas English COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 Miami, FL 33196 -2500 |
| Product Code | GKH |
| CFR Regulation Number | 864.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-03-11 |