OK BIOTECH CO., LTD.

FDA Device Registration & Listing · HSINCHU CITY, TW · Registration 3005862821

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
3005862821
FEI Number
3005862821
Entity Name
OK BIOTECH CO., LTD.
City/State/Country
HSINCHU CITY, TW
Establishment Address
NO. 91, SEC. 2, Gongdao 5th Rd., HSINCHU CITY 30070, TW
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
OK BIOTECH CO., LTD. (Owner Number: 9090860)
Owner / Operator Contact Address
No. 91, Sec. 2, Gongdao 5th Rd., Hsinchu City, TW-HSQ 30070, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TruePoint Equate Walgreens Prodigy OKB OTC hearing aid GV-SA3.60 Prodigy Count-a-Dose Densu Check Prodigy Control Solution Prodigy retail Control Solution Unistrip Control Solution Unistrip Prodigy OKmeter Direct Perfect 3 Multi Smartest Glucowise Multi Smartest Glucowise Prodigy Mini Mist DocSpray Portable Nebulizer SMARTEST PERSONA Prodigy iConnect SOLO V2 Easy Talk Easy Plus II Multi Easy Plus II Smartest Persona II Smartest Persona II Multi SmartTest OK METER Prodigy No Coding Densu Check Densu Check Pocket Densu Check No Coding Prodigy Pocket Prodigy AutoCode Prodigy Voice UniStrip 1 Equate Prodigy Astro Prodigy Astro Pro Prodigy Preferred WowGoHealth SuperCheck Plus Multi SuperCheck Plus Prodigy Choice Prodigy Adjustable Depth Lancing Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2017-01-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-01-23
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-01-18
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2013-01-18
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat Class 2 874.3305 2025-06-25
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-09-24
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-13
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-12-13
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2014-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2014-09-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-01-29
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-01-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-01-29
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2013-01-18
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-06-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-06-27
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-12-22
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2015-12-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-06-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-06-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-01-29
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-01-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-01-29
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2019-01-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-01-29
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-03-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-03-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-03-29
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2012-01-19
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-01-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-08-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-08-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-08-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-07-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-07-25
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-06-27
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2019-06-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-06-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-06-27
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-12-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-12-13
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2006-08-09

Official Correspondent

No official correspondent registered.

US Agent Details

ESTHER LIU Email: us_agent@fdaclass.com Phone: (404) 9323207

Related Public Records

Same Entity

OK BIOTECH CO., LTD.
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
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
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
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000
Z-2165-2011 Instrumentation Laboratory Co. 2
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005862821. Last updated year: 2026. Please use registration number 3005862821 when referencing this establishment in official correspondence.
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