Leica Biosystems Richmond Inc.
FDA Regulatory Profile
Leica Biosystems Richmond Inc. appears in FDA public data with 9 recalls, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3122-2017, Class II) was initiated on July 14, 2017. Its most recent 510(k) clearance was granted on August 19, 2014.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3122-2017 | Class II | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The a | July 14, 2017 |
| Z-3126-2017 | Class II | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diag | July 14, 2017 |
| Z-3123-2017 | Class II | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnost | July 14, 2017 |
| Z-3125-2017 | Class II | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagn | July 14, 2017 |
| Z-3121-2017 | Class II | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro dia | July 14, 2017 |
| Z-3120-2017 | Class II | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro | July 14, 2017 |
| Z-3124-2017 | Class II | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro | July 14, 2017 |
| Z-1948-2016 | Class III | Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro dia | May 6, 2016 |
| Z-2039-2016 | Class III | CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a | May 2, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141136 | LEICA FL800 | August 19, 2014 |