The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-cal 16.
| Device ID | K883850 |
| 510k Number | K883850 |
| Device Name: | MSI-CAL 16 |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| 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 | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-30 |
| Decision Date | 1988-11-22 |