The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Cmv Igg.
| Device ID | K220949 |
| 510k Number | K220949 |
| Device Name: | Architect CMV IgG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Abbott Laboratories Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. Abbott Park, IL 60064 |
| Contact | Shannon Reibling |
| Correspondent | Shannon Reibling Abbott Laboratories Dept 09AA, Bldg. AP8A, 100 Abbott Park Rd. Abbott Park, IL 60064 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-10-27 |