MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634— 510(k) K081286
Substantially EquivalentDako North America, Inc.
FDA 510(k) clearance K081286 for MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634, Substantially Equivalent on 2009-05-08. Applicant: Dako North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Dako North America, Inc.
- Product code
- Code MYA
- Device class
- Class 2
- Regulation
- 21 CFR 864.1860
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carpinteria, CA, US
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More clearances from Dako North America, Inc.
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