Leica Biosystems Richmond Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3126-2017Class IICell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagJuly 14, 2017
Z-3120-2017Class IICell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitroJuly 14, 2017
Z-3124-2017Class IICell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro July 14, 2017
Z-3125-2017Class IICell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnJuly 14, 2017
Z-3123-2017Class IICell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostJuly 14, 2017
Z-3122-2017Class IICell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The aJuly 14, 2017
Z-3121-2017Class IICell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diaJuly 14, 2017
Z-1948-2016Class IIIAriol is an automated scanning microscope and image analysis system. It is intended for in vitro diaMay 6, 2016
Z-2039-2016Class IIICytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is aMay 2, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K141136LEICA FL800August 19, 2014