MORE DIAGNOSTICS INC.

FDA Device Registration & Listing · Los Osos, CA, US · Registration 2085085

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
2085085
FEI Number
1000142648
Entity Name
MORE DIAGNOSTICS INC.
City/State/Country
Los Osos, CA, US
Establishment Address
2020 11TH ST, Los Osos, CA 93402, US
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MORE DIAGNOSTICS INC. (Owner Number: 9009779)
Owner / Operator Contact Address
2020 11TH ST., --, Los Osos, CA 93402, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K050125
PMA Number
N/A

All Registered Proprietary Names

MPA CONTROLS TAC/CSA CONTROLS RAP/TAC/CSA CONTROLS hsTnI Serum Control Clinical Cardiac Control Ev/Tac/CsA Control Ev/Rap/Tac/CsA Rap/Tac/CsA Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2007-10-10
JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-12-16
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2019-05-29
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-10-10

Official Correspondent

Mary Powers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MORE DIAGNOSTICS 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
K882795 Baxter Healthcare Corp DADE(R) CK-MB IMMUNOASSAY CONTROL 1988-08-29
K971777 Instrumentation Laboratory CO QUANTEX ASO-CRP-RF CONTROL 1997-05-27
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04

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3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
2517506 SIEMENS HEALTHCARE DIAGNOSTICS INC. NEWARK, DE, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085085. Last updated year: 2026. Please use registration number 2085085 when referencing this establishment in official correspondence.
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