PRODIGY DIABETES CARE, LLC

FDA Device Registration & Listing · Huntersville, NC, US · Registration 3008789114

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
3008789114
FEI Number
3008789114
Entity Name
PRODIGY DIABETES CARE, LLC
City/State/Country
Huntersville, NC, US
Establishment Address
11621 Patterson Road, Suite 230, Huntersville, NC 28078, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Prodigy Diabetes Care, LLC (Owner Number: 10033726)
Owner / Operator Contact Address
11621 Patterson Road, Suite 230, Huntersville, NC 28078, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K103115
PMA Number
N/A

All Registered Proprietary Names

Prodigy Twist Top Lancets Prodigy Adjustable Depth Lancing Device Prodigy Twist Top Lancet OKB OTC hearing aid GV-SA3.60 Prodigy Preferred Blood Glucose Monitoring System Prodigy Insulin Syringes PRODIGY Astro PRO Blood Glucose Monitoring System PRODIGY Astro PRO Blood Glucose Test Strips PRODIGY Astro Blood Glucose Monitoring System Prodigy AutoCode Blood Glucose Monitoring System Prodigy Voice Blood Glucose Monitoring System Prodigy No Coding Blood Glucose Test Strips Prodigy No Coding Blood Glucose Test Strips Arriva Medical Prodigy Pocket Blood Glucose Monitoring System Prodigy AutoCode Blood Glucose Monitoring System Arriva Medical DDI Ultrasonic Nebulizer System Prodigy Pressure Activated Safety Lancet Count A Dose UniStrip Glucose Control Solution Prodigy Diabetes Management Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-04-26
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-04-26
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-04-26
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-04-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-11-20
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-11-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-11-20
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat Class 2 874.3305 2025-07-01
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2018-10-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-10-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-03-18
FMF Syringe, Piston General Hospital Class 2 880.5860 2016-03-18
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-09-17
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-09-17
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-03-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-03-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-04-28
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2011-04-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-03-13
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2020-03-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-03-13
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2011-04-28
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-04-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2011-04-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-04-10
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2011-12-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2011-12-08

Official Correspondent

Randy Byrd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prodigy Diabetes Care, LLC
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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

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.
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

Similar Registrations

Registration Number Establishment Name Location
3007382160 i-SENS Wonju Factory Wonju-si Gangwon, KR
3006755541 BIONIME USA CORPORATION Ontario, CA, US
8031690 ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant Maniwa Okayama, JP
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
9613304 HTL-STREFA S.A. OZORKOW Lodzkie, PL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008789114. Last updated year: 2026. Please use registration number 3008789114 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.