FDA Registration Active 🇺🇸 United States

CARE LIVING DIAGNOSTICS INC

Reg #: 3031259044 · FEI: 3031259044 · Expires 2026
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12

Registration Details

Registration Name
CARE LIVING DIAGNOSTICS INC
Registration Number
3031259044
FEI Number
3031259044
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
43 Sunflower Ridge Rd
City
South Setauket
State
NY
ZIP
11720
Country
US

Regulatory Submissions

510(k) Number
K242721

Owner / Operator

Firm Name
Care Living Diagnostics Inc
Operator Number
10090880
Address
43 Sunflower Ridge Rd
City
South Setauket
State
NY
Postal Code
11720
Country
US
Correspondent
Wendy Yang

Products

Device Name Product Code
System, Measurement, Blood-Pressure, Non-Invasive DXN
Syringe, Antistick MEG
Syringe, Piston FMF
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
Glucose Oxidase, Glucose CGA
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
System, Test, Blood Glucose, Over The Counter NBW
Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
Needle, Hypodermic, Single Lumen FMI
Nebulizer (Direct Patient Interface) CAF

Proprietary Names

Astrasono Bladder Scanner A3Pro/A3Pro Lite/A3Essential/A5Pro

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility