Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody
FDA 510(k) K110215 · Ventana Medical Systems, Inc.
510(k) numberK110215
Submission
- Device name
- Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
Tucson, AZ, US - Received
- December 29, 2010
- Decision date
- December 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Other 510(k)s with product code MYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor…MYA · Special | Leica Biosystems Newcastle, Limited | 12/07/2018SE |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA · Traditional | Dako Denmark A/S | 12/21/2017SE |
| K122556 | Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11)MYA · Traditional | Leica Biosystems Newcastle, Ltd. | 05/19/2014SE |
| K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone EpiMYA · Traditional | Dako North America, Inc. | 02/12/2013SE |
| K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634MYA · Traditional | Dako North America, Inc. | 05/08/2009SE |
| K061360 | Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)MYA · Traditional | Lab Vision Corp. | 06/27/2006SE |
| K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11)MYA · Abbreviated | Vision Biosystems, Inc. | 05/25/2006SE |
| K012138 | Modification to Acis (Automated Cellular Imaging System)MYA · Traditional | Chroma Vision Medical Systems, Inc. | 09/30/2002SE |
| K013148 | Biogenex Monoclonal Anti-Estrogen Receptor(Clone ER88)MYA · Traditional | Biogenex Laboratories | 02/28/2002SE |
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | Dako Corp. | 03/03/2000SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K242783 | Roche Digital Pathology DxPSY · Special | 12/17/2024SE |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200)PSY · Traditional | 06/14/2024SE |
| K212176 | CINtec HistologyPRB · Traditional | 12/10/2021SE |
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | 05/08/2018SE |
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | 07/16/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | 11/22/2013SE |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | 09/26/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | 09/19/2013SE |
| K121033 | Virtuoso System for Ihc KI-67 (30-9)NOT · Traditional | 09/06/2013SE |
Questions and answers
When was Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody cleared by the FDA?
Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody (K110215) received a 510(k) decision of Substantially Equivalent on December 17, 2012, 719 days after the submission was received.
What is the product code of K110215?
The FDA product code is MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.