Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010420046

FEI Number

3010420046

Entity Name

CITOTEST Labware Manufacturing CO., LTD.

City/State/Country

Haimen Jiangsu, CN

Establishment Address

No.339 Beihai West Road, Haimen Jiangsu 226100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CITOTEST LABWARE MANUFACTURING CO., LTD. (Owner Number: 9077486)

Owner / Operator Contact Address

48 XINXIU ROAD, --, HAIMEN, JIANGSU, CN-NOTA 226100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterile Transport Tube,Saliva collection Kit Sterile Transport Tube Dry Swap Tube Paraffing Melting Pot Tongue dispressor Embedding Container Alcohol Containing Fixative Microsedimentation Centrifuge Specimen Non-sterile Container Cell Collection, Tissue, Tissue Processing Filters NON-STERILE SPECIMEN CONTAINER ,SLIDES MAILER TORAGE BOX Tongue Scraper CITOTEST Micro Ultra Refrigerated Centrifuges for Clinical Use SPECIMEN CONTAINER Harris's Hematoxylin Paraffin Ovens PIPETTE TIPS Clinical Sample Concentrator Mayer's Hematoxylin Sterile Applicator COVERSLIPS MICROSCOPE SLIDES Non Sterile Applicator Sedimentation Rate Tube EMBEDDING CASSETTE Inverted Stage Tissue Culture Microscope PETRI DISHES Fluorescene/UV Microscope Citoswab Collection and Transport Kit Citotest Viral Transport Media Kit CITOTEST PBS/Saline solution Slide Culture Chamber Blender / Mixer Emesis Basis Eosin Y

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-07-06
IDS	Melting Pot, Paraffin	Pathology	Class 1	864.3010	2014-02-12
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2011-11-12
KER	Container, Embedding	Pathology	Class 1	864.3010	2014-02-12
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2014-02-12
GHK	Centrifuge, Microsedimentation	Hematology	Class 1	864.5350	2014-02-12
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-02-12
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2014-02-12
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2005-09-13
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2014-02-12
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2025-04-11
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2014-02-12
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2005-09-14
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2014-02-12
IDR	Ovens, Paraffin	Pathology	Class 1	864.3010	2014-02-12
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2005-09-13
OUL	Thermocycler, Generic	Clinical Chemistry	Class 1	862.2310	2016-12-01
HYL	Hematoxylin Mayer'S	Hematology	Class 1	864.1850	2014-02-12
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2005-09-13
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2005-09-13
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-07-17
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2005-09-13
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2005-09-13
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2014-02-12
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2005-09-13
IBL	Microscope, Inverted Stage, Tissue Culture	Pathology	Class 1	864.3600	2014-02-12
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2005-09-13
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2014-02-12
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-03-26
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-08-11
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2019-07-17
KIY	Chamber, Slide Culture	Hematology	Class 1	864.2240	2014-02-12
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2014-02-12
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2014-02-12
HYB	Eosin Y	Hematology	Class 1	864.1850	2014-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

CITOTEST LABWARE MANUFACTURING CO., LTD.

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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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.

Similar Registrations

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3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3009526936	CGN Huaray Technology Co., Ltd. Suzhou Branch	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010420046. Last updated year: 2026. Please use registration number 3010420046 when referencing this establishment in official correspondence.