The following data is part of a premarket notification filed by Lab Vision Corp. with the FDA for Neomarkers Rabbit Monoclonal Anti-human Estrogen Rece[ptor Antibody (clone Sp1).
| Device ID | K061360 |
| 510k Number | K061360 |
| Device Name: | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) |
| Classification | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Applicant | LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont, CA 94539 |
| Contact | Grace Hsiao-fen Chang |
| Correspondent | Grace Hsiao-fen Chang LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont, CA 94539 |
| Product Code | MYA |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-06-27 |
| Summary: | summary |