The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Fpa Kit.
| Device ID | K854384 |
| 510k Number | K854384 |
| Device Name: | ASSERACHROM FPA KIT |
| Classification | Fibrinopeptide A, Antigen, Antiserum, Control |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | B Le |
| Correspondent | B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | DAN |
| CFR Regulation Number | 866.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-30 |
| Decision Date | 1986-02-04 |