The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Fibri-prest/thrombin-prest Controls.
| Device ID | K884385 |
| 510k Number | K884385 |
| Device Name: | FIBRI-PREST/THROMBIN-PREST CONTROLS |
| Classification | Test, Thrombin Time |
| 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 | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1988-12-28 |