The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus A1care Assay.
| Device ID | K062658 |
| 510k Number | K062658 |
| Device Name: | PRIMUS A1CARE ASSAY |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS CORP. 4231 E. 75TH TERRACE Kansas City, MO 64132 |
| Contact | Britt Einspahr |
| Correspondent | Britt Einspahr PRIMUS CORP. 4231 E. 75TH TERRACE Kansas City, MO 64132 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-06 |
| Decision Date | 2007-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516748223 | K062658 | 000 |