510(k) K220163
- Device
- Her-2, ER, PR IHControls
- Applicant
- Boston Cell Standards, Inc.
- 510(k) number
- K220163
- Product code
- NJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-15
- Date received
- 2022-01-20
- Regulation
- 864.1860
- Classification name
- Control Material, Her-2/Neu, Immunohistochemistry
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steven Bogen
- Address
- 35 Cheryl Dr. Sharon MA US 02067 02067
FDA Registration Numbers#
- 3023212278
- 3036689755
Source Documents#
Other 510(k) Records For Product Code NJW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023335 | QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) | Qc Sciences, LLC | 2003-06-18 |