The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for D-di Test Kit.
| Device ID | K861973 |
| 510k Number | K861973 |
| Device Name: | D-DI TEST KIT |
| Classification | Fibrin Split Products |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le,phd |
| Correspondent | Loc B Le,phd AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-21 |
| Decision Date | 1986-09-04 |