510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SD Biosensor, Inc.

Cheongju-si Chungbuk, KR

SD BIOSENSOR, INC. appears in FDA device records in Cheongju-si Chungbuk, KR. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for SD Biosensor, Inc. between 2014 and 2017. The busiest year on record is 2015, with 3. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for SD Biosensor, Inc., by decision year
YearClearances
20141
20153
20161
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home SystemNBWSubstantially Equivalent
K153201SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K151265SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring SystemNBWSubstantially Equivalent
K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetLCPSubstantially Equivalent
K132929SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent
K123517GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEMNBWSubstantially Equivalent

Registered establishments

FDA registered establishments for SD Biosensor, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30121332123012133212SD BIOSENSOR, INC.C-4th&5th, 16, Deogyeong-daero, Suwon-si Gyeonggi 16690 KR2026
30089594283008959428SD Biosensor, Inc.74, Osongsaengmyeong 4-ro, Osong-eup, Cheongju-si Chungbuk 28161 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1594-2023Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.Class IOpen, Classified
Z-0719-2022STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.Class IOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain