QUANTIMETRIX CORP.

FDA Device Registration & Listing · REDONDO BEACH, CA, US · Registration 2020715

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
2020715
FEI Number
2020715
Entity Name
QUANTIMETRIX CORP.
City/State/Country
REDONDO BEACH, CA, US
Establishment Address
2005 Manhattan Beach Blvd, REDONDO BEACH, CA 90278, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QUANTIMETRIX CORP. (Owner Number: 2020715)
Owner / Operator Contact Address
2005 MANHATTAN BEACH BLVD., --, Redondo Beach, CA 90278, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K925256
PMA Number
N/A

All Registered Proprietary Names

Dipper POCT Urinalysis Dipstick Control CHROMASCOPICS Urinalysis Control with Microscopics AUTION™ CHECK Plus AUTION CHECK Plus Aution Check Plus Microbumin Microalbumin Control Dropper Urine Chemistry Control Sweat Control for Cystic Fibrosis Testing Spinalscopics® Spinal Fluid Cell Count Control Ammonia/Alcohol Control Dropper® A1c Diabetes Control LIPOPRINT LDL KIT LIPOPRINT SYSTEM Dropper® Spinal Fluid Control Spinal Fluid Control Complete D 25-OH Vitamin D Control Quan Ttest Red Total Protein Dropper Urinalysis Dipstick Control Dipper Urinalysis Dipstick Control Dip&Spin Urinalysis Dipstick Microscopics Control Dropper Plus Point -of Care Urinalysis Dipstick Control QuanTscopics® Urinalysis Microscopics Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-05-21
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2017-08-14
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-07-24
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-10-13
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-08
JJR Electrolyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-10-16
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2007-11-10
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2007-11-10
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-11-10
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-06-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 1986-11-07
JHO Electrophoretic Separation, Lipoproteins Clinical Chemistry Class 1 862.1475 1986-11-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-11-10
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-06-07
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2007-11-10
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2003-02-12
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2003-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QUANTIMETRIX CORP.
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
K781077 Dade, Baxter Travenol Diagnostics, Inc. CONTROL, HEMATOLOGY, CH-60 1978-07-27
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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

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 2020715. Last updated year: 2026. Please use registration number 2020715 when referencing this establishment in official correspondence.
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