Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2916657

FEI Number

2916657

Entity Name

LABCON, NORTH AMERICA

City/State/Country

PETALUMA, CA, US

Establishment Address

3700 LAKEVILLE HWY., STE. 200, PETALUMA, CA 94954, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

HELENA LABORATORIES, CORP. (Owner Number: 1618982)

Owner / Operator Contact Address

1530 LINDBERGH DRIVE, Beaumont, TX 77707, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SuperClear Culture Tube Urine Tube SuperClear Mailing Tube SuperClear Sample Vial Urine Time II P-Splitter H-Pette H-Pette with Blade H-Pette II H-Pette without Blade C-Pette SuperClear Mailing Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2012-12-19
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2012-12-19
GJG	Pipette, Quantitative, Hematology	Hematology	Class 1	864.6160	2013-01-22
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2012-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HELENA LABORATORIES, CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1644474	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US
1618982	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2916657. Last updated year: 2026. Please use registration number 2916657 when referencing this establishment in official correspondence.