FDA.reportPublic FDA data

Alere San Diego, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20209522020952Alere San Diego, Inc.1Y2026-01-01829 Towne Center Dr Pomona CA US 91767
20279691000125596Alere San Diego, Inc.1N2026-01-019942 Mesa Rim Road 9942 Mesa Rim Road San Diego CA US 92121
20279691000125596Alere San Diego, Inc.1Y2020-04-259975 SUMMERS RIDGE RD SAN DIEGO CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
138301690299381K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)JHI1999-12-01
3469571690299381K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)JHI1999-12-01
138301638965470K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)JHI1999-12-01
3469571638965470K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)JHI1999-12-01
138301630342626K993065ACON COMBO PREGNANCYJHI1999-10-08
3469571630342626K993065ACON COMBO PREGNANCYJHI1999-10-08
138301060951106K973784TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTSDKZ1997-12-03
138301095996460K934340BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTSLFI1994-12-02
138301650507695K902924BIOSITE DIAGNOSTICS OPIATE SCREENING TESTDJG1990-09-14
3469491301833306K223781Quantisal™ II Oral Fluid Collection DevicePJD2023-07-28
3469571425236626K223179Cholestech LDX ™ SystemCGA2023-09-20
3469491767425920K203527Immunalysis Tapentadol Urine HEIADJG2022-05-09
3469491195830151K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM2021-04-20
3469491111191983K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK2019-11-15
3469491353571752K181553Immunalysis Ethyl Alcohol Enzyme AssayDIC2018-10-31
3469491046115160K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS2016-10-14
3469491330741839K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsDJG2017-06-14
3469491576790142K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF2016-03-18
3469491446235219K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM2015-09-04
138301877872769K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood OnlyLYR2015-08-12
3469491477108247K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM2016-01-05
3469491731950060K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsDJR2015-07-24
3469491927960576K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control SetLDJ2015-06-05
3469491597333591K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control SetDIO2015-06-29
3469491036650033K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine ControlsDJG2015-03-09
3469491850933789K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug ControlsDJG2015-05-20
3469491337306454K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control SetDKZ2015-02-06
3469492026553047K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAYDJG2015-02-12
3469491345031857K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSDJG2014-07-01
3469491089169722K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAYDJG2014-01-17
138301978832971K120615ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTECGA2013-05-15
138301770236369K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALSJJY2010-12-21
3469571770236369K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALSJJY2010-12-21
138301952616054K062361INNOVACON HCG UKTRA TEST DEVICEJHI2006-10-23
3469571952616054K062361INNOVACON HCG UKTRA TEST DEVICEJHI2006-10-23
138301097663091K061718INNOVACON SPECTRUM II TEST CARDDKZ2006-11-13
3469571097663091K061718INNOVACON SPECTRUM II TEST CARDDKZ2006-11-13
138301022440431K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICEDJG2006-04-21
3469571022440431K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICEDJG2006-04-21
138301544415299K060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SETJJX2006-02-16
138301875673542K050878ON CALL MULTI-DRUG HOME TEST CUPLDJ2005-06-08
3469571875673542K050878ON CALL MULTI-DRUG HOME TEST CUPLDJ2005-06-08
138301843804550K050050ON CALL MULTI-DRUG HOME TESTLDJ2005-03-11
3469571843804550K050050ON CALL MULTI-DRUG HOME TESTLDJ2005-03-11
138301046655073K043507ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICEDJG2005-02-25
3469571046655073K043507ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICEDJG2005-02-25
138301364542219K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)KTN2005-02-28
138301958097027K041822ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICEDKZ2004-09-16
3469571958097027K041822ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICEDKZ2004-09-16
138301705456854K041685ACON MULTI-CLIN DRUG SCREEN TEST DEVICEDKZ2004-08-30
3469571705456854K041685ACON MULTI-CLIN DRUG SCREEN TEST DEVICEDKZ2004-08-30
138301938858498K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEJXN2004-05-19
3469571938858498K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEJXN2004-05-19
138301249661940K033299ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICELAF2003-12-12
3469571249661940K033299ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICELAF2003-12-12
138301251658342K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICEDIO2004-02-17
3469571251658342K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICEDIO2004-02-17
138301566799004K024350ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICELYR2003-04-02
138301071022724K022589ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICELAF2002-10-28
3469571071022724K022589ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICELAF2002-10-28
138301448474513K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICELFG2002-07-17
3469571448474513K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICELFG2002-07-17
138301194676382K014247TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002DKZ2002-06-03
138301358184298K013380ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICEDJG2001-12-18
3469571358184298K013380ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICEDJG2001-12-18
138301152941964K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICEDIS2001-11-09
3469571152941964K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICEDIS2001-11-09
138301871200661K012595ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICEDJR2001-10-15
3469571871200661K012595ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICEDJR2001-10-15
138301880985851K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICEJXM2001-09-17
3469571880985851K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICEJXM2001-09-17
138301553562460K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICELCM2001-08-09
3469571553562460K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICELCM2001-08-09
138301405708058K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICEDKZ2001-07-31
3469571405708058K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICEDKZ2001-07-31
138301630585860K011672ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICELAF2001-07-31
3469571630585860K011672ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICELAF2001-07-31
138301814729924K011353ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICEDJG2001-07-30
3469571814729924K011353ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICEDJG2001-07-30
138301180327050K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICEDIO2001-07-09
3469571180327050K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICEDIO2001-07-09
138301574029059K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
3469571574029059K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
138301725968253K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)LDJ2001-03-15
3469571725968253K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)LDJ2001-03-15
138301088117364
138301112766040
138301366071917
138301398382816
138301776256685
3469491069553862
3469491078154003
3469491091700756
3469491121899836
3469491163934201
3469491233137078
3469571261552122
3469491273626909
3469491279991722
3469491287176430
3469491311958744
3469491323486111
3469491327926846
3469571386346976
3469571398382816
3469491432935253
3469491483842003
3469491621109158
3469491632536481
3469491645772987
3469491689406705
3469491706201355
3469491763322951
3469491765248710
3469491767320045
3469491809196785
3469491810367027
3469491892549037
3469491904051568
3469491921907931

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG162022-05-09
DKZ112015-02-06
JHI82006-10-23
LAF72016-03-18
LDJ72015-06-05
DIO52015-06-29
LCM42021-04-20
DIS32016-10-14
JXM32016-01-05
DJR32015-07-24
CGA22023-09-20
LYR22015-08-12
JJY22010-12-21
JXN22004-05-19
LFG22002-07-17
GTY22001-05-07
PJD12023-07-28
QBK12019-11-15
DIC12018-10-31
JJX12006-02-16
KTN12005-02-28
LFI11994-12-02

PMN#

GUDID#

200 records. Showing 1-40. Next