The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for Hemopexin Nephelometric Assay.
| Device ID | K801432 |
| 510k Number | K801432 |
| Device Name: | HEMOPEXIN NEPHELOMETRIC ASSAY |
| Classification | Hemopexin, Antigen, Antiserum, Control |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CZX |
| CFR Regulation Number | 866.5490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-18 |
| Decision Date | 1980-07-08 |