The following data is part of a premarket notification filed by Primus, Inc. with the FDA for Primus Model Clc 330.
| Device ID | K891235 |
| 510k Number | K891235 |
| Device Name: | PRIMUS MODEL CLC 330 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS, INC. 4747 TROOST Kansas City, MO 64110 |
| Contact | Janet Svoboda |
| Correspondent | Janet Svoboda 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 | 1989-03-07 |
| Decision Date | 1989-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516748636 | K891235 | 000 |
| 05391516744164 | K891235 | 000 |
| 05391516744171 | K891235 | 000 |
| 05391516744218 | K891235 | 000 |
| 05391516744270 | K891235 | 000 |
| 05391516744287 | K891235 | 000 |
| 05391516744294 | K891235 | 000 |
| 05391516744317 | K891235 | 000 |
| 05391516744546 | K891235 | 000 |
| 05391516744553 | K891235 | 000 |
| 05391516748155 | K891235 | 000 |
| 05391516748162 | K891235 | 000 |
| 05391516748605 | K891235 | 000 |
| 05391516748612 | K891235 | 000 |
| 05391516748629 | K891235 | 000 |
| 05391516744126 | K891235 | 000 |