The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta(r) - Liquid Anti-xa, Multi Hep Calibrator, Quality Hnf / Ufh, Quality Hbpm / Lmwh.
| Device ID | K111822 |
| 510k Number | K111822 |
| Device Name: | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH |
| Classification | Assay, Heparin |
| Applicant | DIAGNOSTICA STAGO, INC. PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Contact | Carlo D'alessandro |
| Correspondent | Carlo D'alessandro DIAGNOSTICA STAGO, INC. PIAZZA ALBANIA, 10 Rome, IT 00153 |
| 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 | 2011-06-28 |
| Decision Date | 2011-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450011784 | K111822 | 000 |
| 03607450011791 | K111822 | 000 |
| 03607450003819 | K111822 | 000 |
| 03607450003482 | K111822 | 000 |