The following data is part of a premarket notification filed by Qc Sciences, Llc with the FDA for Qcs Her2 Immunocontrols (product No. C010).
| Device ID | K023335 |
| 510k Number | K023335 |
| Device Name: | QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) |
| Classification | Control Material, Her-2/neu, Immunohistochemistry |
| Applicant | QC SCIENCES, LLC 2807 N. PARHAM SUITE 114 Richmond, VA 23294 |
| Contact | Junqi Qian |
| Correspondent | Junqi Qian QC SCIENCES, LLC 2807 N. PARHAM SUITE 114 Richmond, VA 23294 |
| Product Code | NJW |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-06-18 |
| Summary: | summary |