The following data is part of a premarket notification filed by Primus, Inc. with the FDA for Nycocard Hba1c Glycosylated Hemoglobin Assay.
| Device ID | K993131 |
| 510k Number | K993131 |
| Device Name: | NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS, INC. 4747 TROOST Kansas City, MO 64110 |
| Contact | Jimmie K Noffsinger |
| Correspondent | Jimmie K Noffsinger PRIMUS, INC. 4747 TROOST Kansas City, MO 64110 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 2000-05-22 |