The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Rapid Gel 100 Glycated Hemoglobin Assay.
| Device ID | K942009 |
| 510k Number | K942009 |
| Device Name: | PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64114 |
| Contact | Rick Harrison |
| Correspondent | Rick Harrison PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64114 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-09-14 |