ClearanceBrief
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

CodeDeviceRecords
NJTImmunohistochemistry Reagents And Kits23
FSOMicroscope, Surgical, General & Plastic Surgery10
IEOProcessor, Tissue, Automated7
EPTMicroscope, Surgical6
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic3
KPASlide Stainer, Automated2
OUEMicro Total Analysis Instrument System2
ETPStimulator, Caloric-Water1
HKXTonometer, Ac-Powered1
IDPMicrotome, Cryostat1
IDZCassettes, Tissue1
IZISystem, X-Ray, Angiographic1
KIMDevice For Sealing Microsections1
NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity1
REMSpectroscopy Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 20, 2006K061871LEICA MODEL FL800
Leica Microsystems, Inc.
IZI
Jun 7, 1999K990869LEICA AT550
Leica Microsystems, Inc.
HKX

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 9, 2022Leica Microsystems, Inc.
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Open, Classified
EPTNone listed
Dec 9, 2022Leica Microsystems, Inc.
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
Open, Classified
EPTNone listed
Dec 9, 2022Leica Microsystems, Inc.
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Open, Classified
HRMNone listed
Sep 29, 2022Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Open, Classified
FSONone listed
Sep 29, 2022Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Open, Classified
FSONone listed
Sep 29, 2022Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Open, Classified
FSONone listed
Sep 29, 2022Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Open, Classified
FSONone listed
Nov 3, 2021Leica Microsystems, Inc.
Leica Microsystems M220 F12 Microscope Systems
Terminated
FSONone listed
Jul 30, 2021Leica Microsystems, Inc.
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Terminated
NJTNone listed
May 20, 2020Leica Microsystems, Inc.
Leica ARveo and M530 OH6 microscope systems.
Terminated
EPTNone listed
Nov 18, 2019Leica 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
NJTNone listed
Jun 4, 2019Leica Microsystems, Inc.
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Terminated
IDPNone listed
Jan 2, 2019Leica 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
HRMNone listed
Sep 17, 2018Leica Microsystems, Inc.
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Terminated
KPANone listed
Sep 14, 2018Leica Microsystems, Inc.
Leica M525 F20 Surgical Microscope System
Terminated
EPTNone listed
Sep 4, 2018Leica Microsystems, Inc.
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Terminated
KIMNone listed
Jun 25, 2018Leica Microsystems, Inc.
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Terminated
None listed
Jun 13, 2018Leica 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
KPANone listed
Jun 4, 2018Leica 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
EPTNone listed
Sep 25, 2017Leica 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
HRMNone listed
Jun 19, 2017Leica Microsystems, Inc.
Nussloch GmbH ASP6025 Tissue Processor
Open, Classified
IEONone listed
Apr 15, 2016Leica 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
FSONone listed
Apr 5, 2016Leica Microsystems, Inc.
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Terminated
NJTNone listed
Apr 5, 2016Leica 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
NJTNone listed
Mar 22, 2016Leica 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
NJTNone listed
Feb 19, 2016Leica 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
NJTNone listed
Feb 12, 2016Leica 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
NJTNone listed
Nov 25, 2015Leica 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
NJTNone listed
Sep 22, 2015Leica 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
IEONone listed
Sep 17, 2015Leica 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
IEONone listed
Mar 24, 2015Leica 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
NJTNone listed
Nov 6, 2014Leica 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
NJTNone listed
Jun 7, 2014Leica 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
OUENone listed
Jun 7, 2014Leica 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
OUENone listed
Jun 4, 2014Leica 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
NJTNone listed
Jun 2, 2014Leica 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
NJTNone listed
Jul 29, 2013Leica 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
IEONone listed
Jun 3, 2013Leica 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
IDZNone listed
Dec 13, 2012Leica 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
NJTNone listed
Jul 20, 2012Leica 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
FSONone listed
Apr 27, 2012Leica 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
IEONone listed
Mar 21, 2012Leica 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
FSONone listed
Feb 17, 2012Leica 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
NJTNone listed
Feb 17, 2012Leica 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
NJTNone listed
Feb 17, 2012Leica 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
NJTNone listed
Feb 16, 2012Leica 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
ETPNone listed
Sep 9, 2011Leica 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
NJTNone listed
Sep 9, 2011Leica 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
NJTNone listed
Sep 9, 2011Leica 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
NJTNone listed
Jun 20, 2011Leica 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
IEONone listed

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