East West Wisconsin

FDA Device Registration & Listing · WHITEWATER, WI, US · Registration 3002736372

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
3002736372
FEI Number
3004631140
Entity Name
East West Wisconsin
City/State/Country
WHITEWATER, WI, US
Establishment Address
640 N Prospect Dr, WHITEWATER, WI 53190, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
East West (Owner Number: 10058019)
Owner / Operator Contact Address
4170 Ashford Dunwoody Rd, suite 560, Atlanta, GA 30319, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cardiochek Bioscanner plus Cardiochek Bioscanner plus Apnea Risk Evaluation System ARES-Model 620 3301 PULSE OXIMETER MedWand Oximeter Apnea Risk Evaluation System ARES-Model 610 cardiochek Plus Test System, Cardiochek Home Test System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2021-12-06
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2021-12-06
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2021-12-06
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-12-06
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2021-12-06
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2021-12-06
DQA Oximeter Cardiovascular Class 2 870.2700 2021-12-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-08-31
DQA Oximeter Cardiovascular Class 2 870.2700 2022-08-31
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2022-08-31
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-08-31
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2021-12-06
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2021-12-06
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2021-12-06
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2021-12-06
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-12-06

Official Correspondent

Frank Runner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

East West
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013681758 Eastprint Mexico S. DE R.L. DE C.V. Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K790947 Macomb Chemical Co. AUTO ENZYMATIC CHOLESTEROL 1979-06-28
K885023 Em Diagnostic Systems, Inc. CHOLESTEROL TEST ITEM NUMBER: SR1011 1989-02-17
K771508 Instrumentation Laboratory CO MULTISTAT III CHOLESTEROL TEST 1977-09-13
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002736372. Last updated year: 2026. Please use registration number 3002736372 when referencing this establishment in official correspondence.
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