FDA.reportPublic FDA data

OK BIOTECH CO., LTD.

Matched from indexed company URL: OK BioTech Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058628213005862821OK BIOTECH CO., LTD.1N2026-01-01NO. 91, SEC. 2 Gongdao 5th Rd. HSINCHU CITY TW 30070

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00193169001602OKB OTC Hearing Aid - OTC Hearing Aid - Good Voice Everyday+1 626-225-0621support@okbhearing.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
253271304813986K171785WowGoHealth Blood Glucose Monitoring SystemNBW2017-09-15
253271927672372K162430UniStrip1 Generic Blood Glucose Test StripsNBW2017-01-19
253271016898519K160038UniStrip1 Generic Blood Glucose Test StripsNBW2016-07-29
253271504752858K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring SystemNBW2016-07-20
253271020901042K142785PRODIGY iConnect Blood Glucose Monitoring SystemNBW2015-12-17
253271582738138K141351SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2015-05-19
253271289192750K133509EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOONBW2014-02-21
253271787878800K132633OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEMNBW2014-08-14
253271820556083K122525SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEMNBW2013-05-02
253271030619947K120921CLEVER CHOICECGA2012-08-21
253271831023576K100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277NBW2010-05-12
253271675918664K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEMNBW2010-03-02
253271779386948K091815SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268NBW2009-11-16
253271704734206K090609OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEMNBW2010-02-04
253271280784290K073118PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEMNBW2008-03-05
253271737678965K063026OK METER BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-09
253271014577959
253271291157795
253271331067165
253271426218990
253271450940611
253271604579433
253271776058302
253271914169146
253271922501596
253271952235999
253272044286653

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW152017-09-15
CGA12012-08-21

PMN#

GUDID#