The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-hb Hemoglobin Control.
| Device ID | K853776 |
| 510k Number | K853776 |
| Device Name: | MSI-HB HEMOGLOBIN CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | Richard Cocco |
| Correspondent | Richard Cocco 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 | 1985-09-10 |
| Decision Date | 1985-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005860 | K853776 | 000 |
| 00884883005853 | K853776 | 000 |
| 00884883005846 | K853776 | 000 |
| 00884883005839 | K853776 | 000 |