The following data is part of a premarket notification filed by Hycor Biomedical with the FDA for Noveos Immunoanalyzer System, Noveos Specific Ige (sige), Capture Reagent M006, Alternaria.
| Device ID | K220162 |
| 510k Number | K220162 |
| Device Name: | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Hycor Biomedical 7272 Chapman Avenue Garden Grove, CA 92841 |
| Contact | Irene M. Guzman |
| Correspondent | Irene M. Guzman Hycor Biomedical 7272 Chapman Avenue Garden Grove, CA 92841 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-20 |
| Decision Date | 2022-02-18 |