The following data is part of a premarket notification filed by Hycor Biomedical with the FDA for Noveos Specific Ige (sige), Capture Reagent Cat Dander - E001, Felis Domesticus; Noveos Specific Ige (sige), Capture Reagent Timothy Grass- G006, Phleum Pratense.
| Device ID | K200825 |
| 510k Number | K200825 |
| Device Name: | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum Pratense |
| 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 | 2020-03-30 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879023596 | K200825 | 000 |
| 00816879023527 | K200825 | 000 |