The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for The Stachrom Heparin Assay Kit.
| Device ID | K925433 |
| 510k Number | K925433 |
| Device Name: | THE STACHROM HEPARIN ASSAY KIT |
| Classification | Assay, Heparin |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le |
| Correspondent | Loc B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. 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 | 1992-10-28 |
| Decision Date | 1995-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009064 | K925433 | 000 |