510(k) K023335
- Device
- QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
- Applicant
- QC SCIENCES, LLC
- 510(k) number
- K023335
- Product code
- NJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-06-18
- Date received
- 2002-10-07
- Regulation
- 864.1860
- Classification name
- Control Material, Her-2/neu, Immunohistochemistry
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUNQI QIAN
- Address
- 2807 N. Parham Suite 114 Richmond VA US 23294 23294
FDA Registration Numbers#
- 3023212278
- 3036689755
Source Documents#
Other 510(k) Records For Product Code NJW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | 2022-08-15 |
Legacy Summary#
summary
FDA Review#
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