The following data is part of a premarket notification filed by Medical Specialties Laboratories with the FDA for Hematology Control Uni-cell 5, Uni-cell 7 & 8.
| Device ID | K844897 |
| 510k Number | K844897 |
| Device Name: | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | MEDICAL SPECIALTIES LABORATORIES P.O.BOX 659, KENMORE STATION Boston, MA 02215 |
| Contact | Judity A Beatrice |
| Correspondent | Judity A Beatrice MEDICAL SPECIALTIES LABORATORIES P.O.BOX 659, KENMORE STATION Boston, MA 02215 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-03-22 |