The following data is part of a premarket notification filed by Diagnostic Specialties with the FDA for Protein-bound Glucose Assayn Kit.
| Device ID | K930823 |
| 510k Number | K930823 |
| Device Name: | PROTEIN-BOUND GLUCOSE ASSAYN KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Contact | Rinaldo Pagnucco |
| Correspondent | Rinaldo Pagnucco DIAGNOSTIC SPECIALTIES 4 LEONARD ST. Metuchen, NJ 08840 -4338 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1993-08-19 |