510(k) K042884
K042884 is an FDA 510(k) premarket notification submitted by Dakocytomation California, Inc. for the device "DAKOCYTOMATION ER/PR PHARMDX KIT". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Dakocytomation California, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2005
- Date Received
- October 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type