FDA.reportPublic FDA data

ACON LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25314913003516723ACON LABORATORIES, INC.1Y2026-01-019440 Carroll Park Dr SAN DIEGO CA US 92121

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
00682607541065On Call Lancing Device - 1 Lancing Device+1(800)838-9502support@aconlabs.com
00682607541072On Call Lancets (33G) - Lancets+1(800)838-9502support@aconlabs.com
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T - Choleterol lipid panel test device - 25T+1(800)838-9502support@aconlabs.com
00682607690060Mission Cholesterol Meter - Cholesterol meter+1(800)838-9502support@aconlabs.com
00682607690077Mission Cholesterol Optical Check Device - Meter optics checker+1(800)838-9502support@aconlabs.com
00682607690084Mission Cholesterol Control Solution - Cholesterol control solution+1(800)838-9502support@aconlabs.com
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5T - Cholesterol lipid panel test device - 5T+1(800)838-9502support@aconlabs.com
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T - Choleterol lipid panel test device - 25T+1(800)838-9502support@aconlabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
229632044366977K251749Flowflex Plus RSV + Flu A/B + COVID Home TestSCA2025-10-22
229631920753969K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY2025-11-26
229631631045933K250377Flowflex Plus COVID-19 + Flu A/B Home TestSCA2025-05-10
229631122682607K232715Distinct® Digital Pregnancy TestLCX2024-05-31
229631309647317K230828Flowflex COVID-19 Antigen Home TestQYT2023-11-09
229631275787534K193318Distinct® Early Detection Pregnancy TestLCX2020-08-20
229632032465577K192175On Call Express II Blood Glucose Monitoring SystemNBW2019-10-17
229631104768349K191038On Call Express Voice Blood Glucose Monitoring SystemNBW2019-06-12
229631805073895K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring SystemNBW2018-10-03
229632026506748K180196On Call Express Mobile Blood Glucose Monitoring SystemNBW2018-03-07
229631696302742K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisJIN2017-07-06
229632019596339K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH2017-07-11
229631580330481K161867On Call Pro Blood Glucose Monitoring SystemNBW2016-08-05
229632028560816K151595On Call Express Pro Blood Glucose Monitoring SystemNBW2015-09-05
229631559878477K150330Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR2015-04-30
229631351508068K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine ControlKQO2015-05-11
229631317233073K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )JFY2014-12-22
229631908089227K132086ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEMNBW2013-12-19
229631666878856K131469ACON ON CALL DIABETES MANAGEMENT SOFTWARENBW2014-01-06
229631867140701K130284ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEMNBW2013-12-20
229631867847422K123010ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMNBW2012-12-14
229631778203053K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMGKR2013-08-05
229632043431975K122110ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEMCGA2012-11-21
229631966469934K120124FORESIGHT U120 URINE ANALYZERJIL2012-03-06
229631911467257K113332ON CALL CHOSEN LANCING DEVICEFMK2012-04-18
229631539802257K112653ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMSJJX2012-04-09
229631301500668K111371ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEMCGA2011-10-06
229631571578050K111221MISSION U500 URINE ANALYZERJIO2012-01-18
229631989263721K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLJJW2011-02-02
229631330577533K101371ON CALL PLUS DIABETES MONITORING SOFTWARENBW2011-01-07
229631087688092K093879MISSION SALIVA ALCOHOL TEST STRIPDIC2010-08-06
229631168832585K093143MISSION BREATH ALCOHOL DETECTORDJZ2010-01-28
229631526423014K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2009-04-08
229631267271382K070929ACON U120 URINE ANALYZER, MODEL U111-101KQO2007-07-30
229631162562000K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSLJX2007-10-12
229631281423809K061559ACON URINALYSIS REAGENT STRIPSCDM2006-08-11
229631497130770
229631718402334
229631283722724
229631328223644
229631637820334
229631783441929
229631886893564

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW132019-10-17
KQO32015-05-11
SCA22025-10-22
LCX22024-05-31
CHH22017-07-11
CGA22012-11-21
GTY12025-11-26
QYT12023-11-09
JIN12017-07-06
JIR12015-04-30
JFY12014-12-22
GKR12013-08-05
FMK12012-04-18
JJX12012-04-09
JIL12012-03-06
JIO12012-01-18
JJW12011-02-02
DIC12010-08-06
DJZ12010-01-28
LJX12007-10-12
CDM12006-08-11

PMN#

86 records. Showing 1-40. Next

GUDID#

Flowflex Plus RSV + Flu A/B + COVID Home Test - 1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab Guards (2), Nasal Swabs (2); 5 Test per kit (L03A-R1645): Test Cassettes (5), Extraction Buffer Tubes (5), Swab Guards (5), Nasal Swabs (5); 25 Test per kit (L03A-R1745): Test Cassettes (25), Extraction Buffer Tubes (25), Swab Guards (25), Nasal Swabs (25)

Acon Laboratories, Inc.

2025-11-06

200 records. Showing 1-40. Next