Company ยท US
Leica Microsystems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2006. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
60recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | 23 |
| FSO | Microscope, Surgical, General & Plastic Surgery | 10 |
| IEO | Processor, Tissue, Automated | 7 |
| EPT | Microscope, Surgical | 6 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 3 |
| KPA | Slide Stainer, Automated | 2 |
| OUE | Micro Total Analysis Instrument System | 2 |
| ETP | Stimulator, Caloric-Water | 1 |
| HKX | Tonometer, Ac-Powered | 1 |
| IDP | Microtome, Cryostat | 1 |
| IDZ | Cassettes, Tissue | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| KIM | Device For Sealing Microsections | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 1 |
| REM | Spectroscopy Instrument | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system Open, Classified |
EPT | None listed |
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard).
Surgical microscope system Open, Classified |
EPT | None listed |
| Dec 9, 2022 | Leica Microsystems, Inc. Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system Open, Classified |
HRM | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 Open, Classified |
FSO | None listed |
| Sep 29, 2022 | Leica Microsystems, Inc. Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 Open, Classified |
FSO | None listed |
| Nov 3, 2021 | Leica Microsystems, Inc. Leica Microsystems M220 F12 Microscope Systems Terminated |
FSO | None listed |
| Jul 30, 2021 | Leica Microsystems, Inc. BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 Terminated |
NJT | None listed |
| May 20, 2020 | Leica Microsystems, Inc. Leica ARveo and M530 OH6 microscope systems. Terminated |
EPT | None listed |
| Nov 18, 2019 | Leica Microsystems, Inc. BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-li Open, Classified |
NJT | None listed |
| Jun 4, 2019 | Leica Microsystems, Inc. Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications. Terminated |
IDP | None listed |
| Jan 2, 2019 | Leica Microsystems, Inc. Leica M220 F12 surgical microscope
The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied f Terminated |
HRM | None listed |
| Sep 17, 2018 | Leica Microsystems, Inc. BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments Terminated |
KPA | None listed |
| Sep 14, 2018 | Leica Microsystems, Inc. Leica M525 F20 Surgical Microscope System Terminated |
EPT | None listed |
| Sep 4, 2018 | Leica Microsystems, Inc. Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics. Terminated |
KIM | None listed |
| Jun 25, 2018 | Leica Microsystems, Inc. Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. Terminated |
None listed | |
| Jun 13, 2018 | Leica Microsystems, Inc. Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated
Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histologic Terminated |
KPA | None listed |
| Jun 4, 2018 | Leica Microsystems, Inc. Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486
Product Usage:
Intended use of this device is an optica Terminated |
EPT | None listed |
| Sep 25, 2017 | Leica Microsystems, Inc. PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for hu Terminated |
HRM | None listed |
| Jun 19, 2017 | Leica Microsystems, Inc. Nussloch GmbH ASP6025 Tissue Processor Open, Classified |
IEO | None listed |
| Apr 15, 2016 | Leica Microsystems, Inc. Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device.
Intended for Terminated |
FSO | None listed |
| Apr 5, 2016 | Leica Microsystems, Inc. Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues. Terminated |
NJT | None listed |
| Apr 5, 2016 | Leica Microsystems, Inc. Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation Terminated |
NJT | None listed |
| Mar 22, 2016 | Leica Microsystems, Inc. Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566.
Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections. Terminated |
NJT | None listed |
| Feb 19, 2016 | Leica Microsystems, Inc. This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-em Terminated |
NJT | None listed |
| Feb 12, 2016 | Leica Microsystems, Inc. Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin Terminated |
NJT | None listed |
| Nov 25, 2015 | Leica Microsystems, Inc. Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by l Terminated |
NJT | None listed |
| Sep 22, 2015 | Leica Microsystems, Inc. The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments.
The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, Terminated |
IEO | None listed |
| Sep 17, 2015 | Leica Microsystems, Inc. The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments.
The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination thr Terminated |
IEO | None listed |
| Mar 24, 2015 | Leica Microsystems, Inc. Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining.
Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy Terminated |
NJT | None listed |
| Nov 6, 2014 | Leica Microsystems, Inc. Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a pre Terminated |
NJT | None listed |
| Jun 7, 2014 | Leica Microsystems, Inc. Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V.
Terminated |
OUE | None listed |
| Jun 7, 2014 | Leica Microsystems, Inc. Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V.
In Terminated |
OUE | None listed |
| Jun 4, 2014 | Leica Microsystems, Inc. Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use. Terminated |
NJT | None listed |
| Jun 2, 2014 | Leica Microsystems, Inc. Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use. Terminated |
NJT | None listed |
| Jul 29, 2013 | Leica Microsystems, Inc. Leica ASP6025 Vacuum Tissue Processor
The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin Terminated |
IEO | None listed |
| Jun 3, 2013 | Leica Microsystems, Inc. LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is fo Terminated |
IDZ | None listed |
| Dec 13, 2012 | Leica Microsystems, Inc. Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Terminated |
NJT | None listed |
| Jul 20, 2012 | Leica Microsystems, Inc. Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland
Product Usage: The intended use of this device is for Terminated |
FSO | None listed |
| Apr 27, 2012 | Leica Microsystems, Inc. ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an au Terminated |
IEO | None listed |
| Mar 21, 2012 | Leica Microsystems, Inc. Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, article 10448196, and the Leica M844 C19 Surgical Microsc Terminated |
FSO | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell ori Terminated |
NJT | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origi Terminated |
NJT | None listed |
| Feb 17, 2012 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. Terminated |
NJT | None listed |
| Feb 16, 2012 | Leica Microsystems, Inc. Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Ti Terminated |
ETP | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Bal Terminated |
NJT | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West Terminated |
NJT | None listed |
| Sep 9, 2011 | Leica Microsystems, Inc. Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Be Terminated |
NJT | None listed |
| Jun 20, 2011 | Leica Microsystems, Inc. Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0005.
This tissue processor prepares tissue samples for sectioning by tran Terminated |
IEO | None listed |
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