The following data is part of a premarket notification filed by Medical Specialties Intl., Inc. with the FDA for Hematology Control.
| Device ID | K895373 |
| 510k Number | K895373 |
| Device Name: | HEMATOLOGY CONTROL |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | MEDICAL SPECIALTIES INTL., INC. 3005 HADLEY RD. South Plainfield, NJ 07080 |
| Contact | Ron Devita |
| Correspondent | Ron Devita MEDICAL SPECIALTIES INTL., INC. 3005 HADLEY RD. South Plainfield, NJ 07080 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-29 |
| Decision Date | 1989-10-06 |