Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004192065

FEI Number

3004192065

Entity Name

SENSOR HEALTH PRODUCTS, INC.

City/State/Country

CAMBRIDGE Ontario, CA

Establishment Address

6-110 TURNBULL COURT, CAMBRIDGE Ontario N1T 1K6, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SENSOR HEALTH PRODUCTS, INC. (Owner Number: 9072536)

Owner / Operator Contact Address

6-110 Turnbull Court, Cambridge, CA-ON N1T 1K6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K925603

PMA Number

N/A

All Registered Proprietary Names

FORMALIN 10% NEUTRAL BUFFERED Ethicon Inc CONTAINER, SPECIMEN, NON-STERILE Ethicon Inc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2013-09-06
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2013-09-06
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-09-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-14
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2005-04-26
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2021-09-14
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2025-05-23
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2025-05-23
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2025-05-14
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2025-05-23
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2013-09-06
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-05-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-05-14
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2025-05-14
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2013-03-01
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2025-05-23
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2013-09-06
JNL	Immunochemical, Thyroglobulin Autoantibody	Immunology	Class 2	866.5870	2025-05-23
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-05-23
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2025-05-23
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2013-09-06
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2013-09-06
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2013-09-06
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2013-09-06
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-09-06
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2013-09-06
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2013-09-06
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2013-09-06
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2013-09-06
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2013-09-06
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2013-09-06
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-06-01
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2013-09-06
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2013-09-06
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-09-06
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-05-14
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2013-09-06
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-09-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-26
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2013-09-06
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2013-09-06
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2025-05-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2025-05-14
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2025-05-14
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2025-05-23
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-09-14
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2022-06-01
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2022-06-01
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2022-06-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-06-01
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2022-06-01
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-06-01
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2022-06-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2025-05-14

Official Correspondent

Paul Williamson

US Agent Details

Misty McWhorter-Darley Business: mercedes scientific Email: mmcwhorter@mercedesscientific.com Phone: (800) 3312716

Related Public Records

Same Entity

SENSOR HEALTH PRODUCTS, 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K880678	Ventrex Laboratories, Inc.	MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY	1988-04-05
K072500	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE/SERUM TEST	2009-04-21
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004192065. Last updated year: 2026. Please use registration number 3004192065 when referencing this establishment in official correspondence.