The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-diff Plus.
| Device ID | K880270 |
| 510k Number | K880270 |
| Device Name: | MSI-DIFF PLUS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | Ron Devita |
| Correspondent | Ron Devita MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-21 |
| Decision Date | 1988-03-01 |