The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Ix:ag.
| Device ID | K854312 |
| 510k Number | K854312 |
| Device Name: | ASSERACHROM IX:AG |
| 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 | 1985-10-28 |
| Decision Date | 1986-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009439 | K854312 | 000 |