Trukera Medical

FDA Device Registration & Listing · Temecula, CA, US · Registration 3007137761

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
3007137761
FEI Number
3007137761
Entity Name
Trukera Medical
City/State/Country
Temecula, CA, US
Establishment Address
42309 Winchester Rd, Suite I, Temecula, CA 92590, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Trukera Medical (Owner Number: 10026657)
Owner / Operator Contact Address
42309 Winchester Rd, Suite I, Temecula, CA 92590, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K083184
PMA Number
N/A

All Registered Proprietary Names

ScoutPro Osmolarity System TearLab Osmolarity System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OND Osmolality Of Tears Clinical Chemistry Class 1 862.1540 2009-07-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trukera Medical
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007137761. Last updated year: 2026. Please use registration number 3007137761 when referencing this establishment in official correspondence.
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