CLIAWAIVED,INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3008583799

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
3008583799
FEI Number
3008583799
Entity Name
CLIAWAIVED,INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
2721 Loker Ave W, Carlsbad, CA 92010, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Cliawaived, Inc. (Owner Number: 10035746)
Owner / Operator Contact Address
2721 Loker Ave West, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K990658
PMA Number
N/A

All Registered Proprietary Names

THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2011-03-21

Official Correspondent

Tim Drapeau

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cliawaived, 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
K850376 Terumo Medical Corp. TERUMO SENSIBEAD EIA TSH KIT 1985-03-04
K843395 Hybritech, Inc. ENCORE TSH REAGENT 1984-10-11
K854087 Organon Teknika Corp. NML TSH IRMA 1985-10-25
K151792 Siemens Healthcare Diagnostics, Inc. Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System 2015-11-20
K141999 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR TSH 2015-04-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2025 Qualigen Inc 2
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020 Roche Diagnostics Operations, Inc. 2
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Centaur XPT Immunoassay System

Similar Registrations

Registration Number Establishment Name Location
3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
1319808 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US
9680746 Beckman Coulter Ireland Inc O CALLAGHANS MILLS Clare, IE
2432235 Siemens Healthcare Diagnostics Inc. Tarrytown, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008583799. Last updated year: 2026. Please use registration number 3008583799 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.