DAKOCYTOMATION ER/PR PHARMDX KIT— 510(k) K042884
Substantially EquivalentDakocytomation California, Inc.
FDA 510(k) clearance K042884 for DAKOCYTOMATION ER/PR PHARMDX KIT, Substantially Equivalent on 2005-02-15. Applicant: Dakocytomation California, Inc.. Device class: 2.
Clearance details
- Applicant
- Dakocytomation California, Inc.
- Product code
- Code MXZ
- 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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