The following data is part of a premarket notification filed by Hycor Biomedical with the FDA for Noveos Immunoassay Analyzer, Noveos Specific Ige (sige) Assay, Capture Reagent D001, Dermatophagoides Pteronyssinus.
| Device ID | K182479 |
| 510k Number | K182479 |
| Device Name: | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides Pteronyssinus |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Hycor Biomedical 7272 Chapman Avenue Garden Grove, CA 92841 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani 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 | 2018-09-10 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879023503 | K182479 | 000 |
| 00816879023008 | K182479 | 000 |
| 00816879023015 | K182479 | 000 |
| 00816879023022 | K182479 | 000 |
| 00816879023039 | K182479 | 000 |
| 00816879023046 | K182479 | 000 |
| 00816879023053 | K182479 | 000 |
| 00816879023077 | K182479 | 000 |
| 00816879023091 | K182479 | 000 |
| 00816879023107 | K182479 | 000 |
| 00816879023114 | K182479 | 000 |
| 00816879023169 | K182479 | 000 |
| 00816879022995 | K182479 | 000 |