The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Assera Plate Ix:ag Kit.
| Device ID | K854014 |
| 510k Number | K854014 |
| Device Name: | ASSERA PLATE IX:AG KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1986-01-03 |