LGM INTERNATIONAL INC.

FDA Device Registration & Listing · Melbourne, FL, US · Registration 3004421347

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
3004421347
FEI Number
3004421347
Entity Name
LGM INTERNATIONAL INC.
City/State/Country
Melbourne, FL, US
Establishment Address
295 North Dr Ste A, Melbourne, FL 32934, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LGM INTERNATIONAL INC. (Owner Number: 9059951)
Owner / Operator Contact Address
295-A North Drive, --, Melbourne, FL 32934, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LIQUI-PREP SPECIAL PROCESSING KIT LIQUI-PREP CYTOLOGY PROCESSING KIT Auto-LP LIQUI-PREP SPECIAL PROCESSING KIT LIQUI-PREP CYTOLOGY PROCESSING KIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LDZ Fixative, Alcohol Containing Pathology Class 1 864.4010 2003-12-02
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2011-11-28
LEB Mounting Media Pathology Class 1 864.4010 2003-12-02

Official Correspondent

RONALD LENTZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LGM INTERNATIONAL INC.
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
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-0002-2013 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.

Similar Registrations

Registration Number Establishment Name Location
3017970519 CHAPTEC AMERICA Montreal Quebec, CA
3003887639 DIAMOND WIPES INTERNATIONAL, INC. Chino, CA, US
3010420046 CITOTEST Labware Manufacturing CO., LTD. Haimen Jiangsu, CN
3033524192 Noul Co., Ltd. Yongin Si Gyeonggi, KR
3002805583 VOLUSOL Tooele, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004421347. Last updated year: 2026. Please use registration number 3004421347 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.