510(k) K023335
K023335 is an FDA 510(k) premarket notification submitted by Qc Sciences, LLC for the device "QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)". The FDA issued a decision of Substantially Equivalent on Jun 18, 2003. 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
- Jun 18, 2003
- Date Received
- Oct 7, 2002
- 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.