The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Prodcts Gmbh with the FDA for Innovance(r) Heparin Reagents, Innovance(r) Heparin Calibrator, Innovance(r) Heparin Uf And Heparin Lmw Controls.
| Device ID | K162540 |
| 510k Number | K162540 |
| Device Name: | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF And Heparin LMW Controls |
| Classification | Assay, Heparin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH EMIL-VON BEHRING STR 76 Marburg, DE 35041 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH EMIL-VON BEHRING STR 76 Marburg, DE 35041 |
| Product Code | KFF |
| Subsequent Product Code | GGN |
| Subsequent Product Code | JIS |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-12 |
| Decision Date | 2017-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768017438 | K162540 | 000 |
| 00630414229522 | K162540 | 000 |
| 00630414229546 | K162540 | 000 |
| 00630414639864 | K162540 | 000 |
| 00630414229515 | K162540 | 000 |
| 00630414229539 | K162540 | 000 |
| 00842768017063 | K162540 | 000 |
| 00842768017070 | K162540 | 000 |
| 00842768017087 | K162540 | 000 |
| 00842768017094 | K162540 | 000 |
| 00842768017100 | K162540 | 000 |
| 00630414639833 | K162540 | 000 |