The following data is part of a premarket notification filed by Primus Corporation Dba Trinity Biotech with the FDA for Premier Hb9210 Hba1c Analyzer.
| Device ID | K112015 |
| 510k Number | K112015 |
| Device Name: | PREMIER HB9210 HBA1C ANALYZER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PRIMUS CORPORATION DBA TRINITY BIOTECH 4231 E. 75TH TERRACE Kansas City, MO 64132 |
| Contact | Britt Einspahr |
| Correspondent | Britt Einspahr PRIMUS CORPORATION DBA TRINITY BIOTECH 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 | 2011-07-13 |
| Decision Date | 2011-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516748148 | K112015 | 000 |
| 05391516744782 | K112015 | 000 |
| 05391516744775 | K112015 | 000 |
| 05391516744768 | K112015 | 000 |
| 05391516744751 | K112015 | 000 |
| 05391516744379 | K112015 | 000 |
| 05391516749930 | K112015 | 000 |
| 05391516749923 | K112015 | 000 |
| 05391516749916 | K112015 | 000 |
| 05391516749909 | K112015 | 000 |
| 05391516744799 | K112015 | 000 |
| 05391516744812 | K112015 | 000 |
| 05391516748131 | K112015 | 000 |
| 05391516748124 | K112015 | 000 |
| 05391516748117 | K112015 | 000 |
| 05391516748100 | K112015 | 000 |
| 05391516748094 | K112015 | 000 |
| 05391516748087 | K112015 | 000 |
| 05391516748070 | K112015 | 000 |
| 05391516748063 | K112015 | 000 |
| 05391516748056 | K112015 | 000 |
| 05391516749893 | K112015 | 000 |