The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Liquid Calibrator For Ghb/a1c Level 1 And Level 2.
| Device ID | K994045 |
| 510k Number | K994045 |
| Device Name: | PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS CORP. 7235 CENTRAL Kansas City, MO 64114 |
| Contact | Jim Noffsinger |
| Correspondent | Jim Noffsinger PRIMUS CORP. 7235 CENTRAL Kansas City, MO 64114 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 1999-12-21 |