510(k) K220163
K220163 is an FDA 510(k) premarket notification submitted by Boston Cell Standards, Inc. for the device "Her-2, ER, PR IHControls". The FDA issued a decision of Substantially Equivalent on Aug 15, 2022. The device falls under product code NJW (Control Material, Her-2/Neu, Immunohistochemistry), a Class II device regulated under 21 CFR 864.1860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 2022
- Date Received
- Jan 20, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control Material, Her-2/Neu, Immunohistochemistry
- Device Class
- Class II
- Regulation Number
- 864.1860
- Review Panel
- PA
- Submission Type
- 510(k)
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.