JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

FDA Device Registration & Listing · JIANGYAN Jiangsu, CN · Registration 3013894805

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013894805
FEI Number
3013894805
Entity Name
JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.
City/State/Country
JIANGYAN Jiangsu, CN
Establishment Address
NO. 16 ZHANQIAN ROAD, JIANGYAN Jiangsu 225500, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD. (Owner Number: 10055971)
Owner / Operator Contact Address
No.16 Zhanqian Road, Jiangyan, CN-JS CN-32, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Petri dish Pipette tips Test tube cap Cryo tube Cryogenic vial Cryovial Centrifuge Transport tube Absorbent Tipped Applicator Disposable swab Pipette tip Serological piette Transport tube DISPOSABLE SAMPLING COLLECTION KIT Blood Collection Tube ESR tube Centrifuge tube Culture tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIZ Dish, Tissue Culture Hematology Class 1 864.2240 2023-09-05
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2017-11-10
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2020-05-06
QUJ Automated Cryopreservation Storage System Obstetrics/Gynecology Class 2 884.6120 2023-09-05
KSO Centrifuge, Blood-Bank For In Vitro Diagnostic Use Hematology Class 1 864.9275 2022-07-08
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2020-05-07
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-03-19
PUC Microtools, Assisted Reproduction (Pipettes), Exempt Obstetrics/Gynecology Class 2 884.6130 2023-09-05
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2023-09-05
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2020-06-24
KST System, Blood Collection, Vacuum-Assisted, Manual Hematology Class 1 864.9125 2022-07-12
GHC Tube, Sedimentation Rate Hematology Class 1 864.6700 2023-08-23
KJG Tube, Tissue Culture Pathology Class 1 864.3010 2023-09-05
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2020-05-06
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2019-11-21

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

JIANGSU KANGJIAN MEDICAL APPARATUS 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
K851403 Ventrex Laboratories, Inc. VENTREZYME ALLERGEN DATA REDUCTION SYSTEM 1985-06-21
K761290 Nuclear Medical Laboratories, Inc. COMPU-PET 300 1977-02-24
K770210 G.D. Searle and Co. ANALYTIX AUTO SAMPLE PREP. STA. 1600 1977-02-14

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-0002-2013 Beckman Coulter Inc. 1
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012 Beckman Coulter Inc. 1
Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013894805. Last updated year: 2026. Please use registration number 3013894805 when referencing this establishment in official correspondence.
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