The following data is part of a premarket notification filed by Diagnostica-stago with the FDA for Rotachrom Heparin And Sta -rotachrom Heparin.
| Device ID | K010455 |
| 510k Number | K010455 |
| Device Name: | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN |
| Classification | Assay, Heparin |
| Applicant | DIAGNOSTICA-STAGO 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le |
| Correspondent | Andrew Loc B Le DIAGNOSTICA-STAGO 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-06-07 |