Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010692993

FEI Number

3010692993

Entity Name

DIAPATH S.P.A.

City/State/Country

Martinengo Bergamo, IT

Establishment Address

via savoldini 71, Martinengo Bergamo 24057, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diapath S.p.A. (Owner Number: 10049807)

Owner / Operator Contact Address

via savoldini 71, Martinengo, IT-BG 24057, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CytoPath Disc IDL - MICROTOME, ACCESSORIES MXT - DEVICE, ACCESSORY, COOLING PLATE FOR TISSUE EMBEDDING STATION Galileo Series 2 Tissue cassettes Donatello Series 2 Empty tank for PWD (wax drain) for Donatello Tissue Processor - Series 2 Donatello Series Empty tank for PWD (wax drain) for Donatello Series GreenFix KIO - SLIDE STAINER, IMMERSION TYPE Paraffin 56-58 C RFID Donatello Series 2 Paraffin 56-58 C Paraffin 56-58 C RFID Donatello Series 3 Dante Embedding Module LDY - FIXATIVE, FORMALIN-CONTAINING Formalin tank for Donatello Tissue Processor - series 2 Red safety capsule, pre-filled with formalin Formalin tank for Donatello Tissue Processor - series 3 SafeCapsule Prostate Biopsy Kit LEB - MOUNTING MEDIA Cristallo NNK - CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE Microclearing tank for Donatello Tissue Processor - Series 2 KEM - AGENT, CLEARING Ottix Plus tank for Donatello Tissue Processor - Series 2 Xylol tank 5LT for Donatello Tissue Processor - Series 2 Diasolv tank for Donatello Tissue Processor - Series 2 Microclearing tank for Donatello Tissue Processor - Series 3 Ottix Plus tank for Donatello Tissue Processor - Series 3 Xylol tank 5LT for Donatello Tissue Processor - Series 3 Diasolv tank for Donatello Tissue Processor - Series 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2025-03-11
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2018-07-31
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2015-08-04
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2015-08-03
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2021-02-25
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2015-08-04
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2018-02-21
KIO	Slide Stainer, Immersion Type	Pathology	Class 1	864.3800	2019-02-15
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2021-06-25
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2025-07-14
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2018-10-18
LEB	Mounting Media	Pathology	Class 1	864.4010	2019-03-07
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2018-09-25
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2019-02-19

Official Correspondent

Chiara Bergamini

US Agent Details

Antonio Lizarraga Business: StatLab Medical Products Email: ALizarraga@statlab.com Phone: (800) 4423573

Related Public Records

Same Entity

Diapath S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
Z-0012-2015	Richard-Allan Scientific Company	1	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0014-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0015-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Similar Registrations

Registration Number	Establishment Name	Location
3013548489	ADVANCE SENTRY CORPORATION	Markham Ontario, CA
3011781201	GUANGZHOU KOMASPEC MECHANICAL AND ELECTRICAL PRODUCTS MANUFA	Huashan Town, Huadu District, Guangdong, CN
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
2029275	Sterigenics U.S., LLC	Corona, CA, US
3008624479	MEDIKAN CO., Ltd.	Gangseo-gu Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010692993. Last updated year: 2026. Please use registration number 3010692993 when referencing this establishment in official correspondence.