The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Refractrol-sp.
| Device ID | K926095 |
| 510k Number | K926095 |
| Device Name: | REFRACTROL-SP |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | David Shick |
| Correspondent | David Shick MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-02 |
| Decision Date | 1993-01-26 |