FDA 510(k) Applications for Medical Device Product Code "NJW"
(Control Material, Her-2/Neu, Immunohistochemistry)

FDA 510(k) Number Applicant Device Name Decision Date
K220163 Boston Cell Standards, Inc. Her-2, ER, PR IHControls 08/15/2022
K023335 QC SCIENCES, LLC QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) 06/18/2003


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