Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010152370

FEI Number

3010152370

Entity Name

KOVA INTERNATIONAL INC

City/State/Country

Garden Grove, CA, US

Establishment Address

7272 Chapman Ave Suite B, Garden Grove, CA 92841, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LGC Clinical Diagnostics (Owner Number: 10043604)

Owner / Operator Contact Address

7272 Chapman Ave, Suite B, Garden Grove, CA 92841, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kova KO-LEC-PAC KOVA System Value Pac 500 KOVA System Super Pac 1000 KOVA System Pac II Kova Economy Tube Kova Super Tube KOVA Cap KOVA-poc System Pack Kova-Trol Refractrol Kova-Trol Kova Slide II Kova Slide II with Grid Kova Fast-Read 102 KOVA-poc System Pack Kova BVS100H Kova Glasstic Slide 10 Kova Glasstic Slide 10 with Grid Kova Petter Kova Stain

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-01-22
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2016-07-12
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-03-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-03-04
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-03-04
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2013-03-21
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2013-03-21
ICF	Crystal Violet For Histology	Hematology	Class 1	864.1850	2013-03-21

Official Correspondent

Gary Padron

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LGC Clinical Diagnostics

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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
3004472848	VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED	ZHANGJIAGANG Jiangsu, CN
3016577639	ACOSTA MEDICAL GROUP INC.	Houston, TX, US
3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3013187142	ENDURE INDUSTRIES, INC.	Homer, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010152370. Last updated year: 2026. Please use registration number 3010152370 when referencing this establishment in official correspondence.