The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Fibrin(ogen) Degradation Products(fdp).
| Device ID | K801841 |
| 510k Number | K801841 |
| Device Name: | FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP) |
| Classification | Fibrin Split Products |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-01 |
| Decision Date | 1980-10-10 |