The following data is part of a premarket notification filed by J.t. Baker Chemical Co. with the FDA for J.t. Baker Immuno. A Nephelometric Assay.
| Device ID | K801283 |
| 510k Number | K801283 |
| Device Name: | J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY |
| Classification | Iga, Antigen, Antiserum, Control |
| Applicant | J.T. BAKER CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-29 |
| Decision Date | 1980-06-30 |