DAKOCYTOMATION ER/PR PHARMDX KIT

Immunohistochemistry Assay, Antibody, Progesterone Receptor

DAKOCYTOMATION CALIFORNIA, INC.

The following data is part of a premarket notification filed by Dakocytomation California, Inc. with the FDA for Dakocytomation Er/pr Pharmdx Kit.

Pre-market Notification Details

Device IDK042884
510k NumberK042884
Device Name:DAKOCYTOMATION ER/PR PHARMDX KIT
ClassificationImmunohistochemistry Assay, Antibody, Progesterone Receptor
Applicant DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria,  CA  93013
ContactTiffany D Almeroth
CorrespondentTiffany D Almeroth
DAKOCYTOMATION CALIFORNIA, INC. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeMXZ  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-19
Decision Date2005-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700571105146 K042884 000
05700571104897 K042884 000
05700571104354 K042884 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.