Modification to Acis (Automated Cellular Imaging System)
FDA 510(k) K012138 · Chroma Vision Medical Systems, Inc.
510(k) numberK012138
Submission
- Device name
- Modification to Acis (Automated Cellular Imaging System)
- Applicant
- Chroma Vision Medical Systems, Inc.
San Juan Capistrano, CA, US - Received
- July 10, 2001
- Decision date
- September 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyMYA · Traditional | Ventana Medical Systems, Inc. | 12/17/2012SE |
| 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 |
| 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 |
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Questions and answers
When was Modification to Acis (Automated Cellular Imaging System) cleared by the FDA?
Modification to Acis (Automated Cellular Imaging System) (K012138) received a 510(k) decision of Substantially Equivalent on September 30, 2002, 447 days after the submission was received.
What is the product code of K012138?
The FDA product code is MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.