The following data is part of a premarket notification filed by Primus, Inc. with the FDA for Diabetes Care(tm) Test Package For The Clc 330(tm).
| Device ID | K896582 |
| 510k Number | K896582 |
| Device Name: | DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS, INC. 4747 TROOST Kansas City, MO 64110 |
| Contact | Jace Rexroad |
| Correspondent | Jace Rexroad 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 | 1989-11-17 |
| Decision Date | 1990-06-28 |