Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009407607

FEI Number

3009407607

Entity Name

ACCUMAX LAB DEVICES PVT LTD

City/State/Country

Gandhi nagar Gujarat, IN

Establishment Address

Plot 16, Electronic Park SEZ, GIDC, Sector 26, Gandhi nagar Gujarat 382026, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Accumax Lab Devices Pvt Ltd (Owner Number: 10077235)

Owner / Operator Contact Address

Plot 16, Electronic Park SEZ, GIDC, Sector 26, Gandhi nagar, IN-GJ 382026, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diamond Serologic controller Centrifuge Non sterile Reservoir Non Sterile Diamond Diamond Apex Diamond Junior Diamond Pro Diamond Advance CRYOVIALS iFuge D06

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2020-08-22
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-08-22
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2020-08-22
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2023-07-12
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2023-10-19

Official Correspondent

Ms. Amee Parikh

US Agent Details

Dennis Hoeft Business: Globe Scientific. Inc. Email: d.ackley@globescientific.com Phone: (201) 5991400

Related Public Records

Same Entity

Accumax Lab Devices Pvt 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-0002-2013	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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3016068451	LABTURBO BIOTECH CORPORATION	Taipei, TW
3007118747	EUROIMMUN US INC.	Mountain Lakes, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009407607. Last updated year: 2026. Please use registration number 3009407607 when referencing this establishment in official correspondence.