PRECISION DIABETES, INC.

FDA Device Registration & Listing · Raleigh, NC, US · Registration 3016698405

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
3016698405
FEI Number
3016698405
Entity Name
PRECISION DIABETES, INC.
City/State/Country
Raleigh, NC, US
Establishment Address
5540 Centerview Drive, Suite 200, Raleigh, NC 27606, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Precision Diabetes, Inc. (Owner Number: 10068056)
Owner / Operator Contact Address
5540 Centerview Drive, Suite 200, Raleigh, NC 27606, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K031604
PMA Number
N/A

All Registered Proprietary Names

GlycoMark

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOZ Assay, 1,5-Anhydroglucitol (15ag) Hematology Class 2 864.7470 2020-04-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-04-08
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2020-04-08

Official Correspondent

Eric Button

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Diabetes, 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
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-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.

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3014353121 VIDAN DIAGNOSTICS, LLC San Antonio, TX, US
3008514395 Telcare, LLC Linwood, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016698405. Last updated year: 2026. Please use registration number 3016698405 when referencing this establishment in official correspondence.
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