The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Fdp Assay-20 Test Kit.
| Device ID | K852848 |
| 510k Number | K852848 |
| Device Name: | FDP ASSAY-20 TEST KIT |
| Classification | Fibrin Split Products |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Thomas Alter |
| Correspondent | Thomas Alter 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 | 1985-07-05 |
| Decision Date | 1985-10-10 |