The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Liquid Control For Ghb/alc Level I And Level Ii.
| Device ID | K992921 |
| 510k Number | K992921 |
| Device Name: | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
| Contact | Jimmie K Noffsinger |
| Correspondent | Jimmie K Noffsinger PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 1999-11-12 |
| Summary: | summary |