The following data is part of a premarket notification filed by Hycor Biomedical with the FDA for Noveos Immunoanalyzer System, Noveos Specific Ige (slge), Capture Reagent D002, Dermatophagoides Farinae.
| Device ID | K191510 |
| 510k Number | K191510 |
| Device Name: | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides Farinae |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Hycor Biomedical 7272 Chapman Avenue Garden Grove, CA 92841 |
| Contact | Kaitlyn Weinkauf |
| Correspondent | Kaitlyn Weinkauf 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 | 2019-06-06 |
| Decision Date | 2019-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879023510 | K191510 | 000 |