The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Rotachrom Heparin Test Kit.
| Device ID | K943515 |
| 510k Number | K943515 |
| Device Name: | ROTACHROM HEPARIN TEST KIT |
| Classification | Assay, Heparin |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le |
| Correspondent | Andrew Loc B Le AMERICAN BIOPRODUCTS CO. 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 | 1994-07-21 |
| Decision Date | 1995-08-31 |