The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Mh015 (differential Cell Counter).
| Device ID | K930913 |
| 510k Number | K930913 |
| Device Name: | COULTER MH015 (DIFFERENTIAL CELL COUNTER) |
| Classification | Counter, Differential Cell |
| Applicant | COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Contact | Benita Bradford |
| Correspondent | Benita Bradford COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1993-08-23 |