FDA.reportPublic FDA data

Alere San Diego Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20209522020952Alere San Diego Inc.1Y2020-04-25829 Towne Center Drive Pomona CA US 91767

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1894081121899836K942435SALIVA SAMPLERPJD1995-08-21
1894081111191983K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK2019-11-15
1894081903920553K183048Quantisal II Oral Fluid Collection DevicePJD2019-07-29
1894081353571752K181553Immunalysis Ethyl Alcohol Enzyme AssayDIC2018-10-31
1894081046115160K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS2016-10-14
1894081330741839K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsDJG2017-06-14
1894081576790142K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF2016-03-18
1894081446235219K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM2015-09-04
1894081477108247K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM2016-01-05
1894081731950060K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsDJR2015-07-24
1894081927960576K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control SetLDJ2015-06-05
1894081597333591K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control SetDIO2015-06-29
1894081036650033K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine ControlsDJG2015-03-09
1894081850933789K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug ControlsDJG2015-05-20
1894081337306454K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control SetDKZ2015-02-06
1894082026553047K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAYDJG2015-02-12
1894081345031857K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSDJG2014-07-01
1894081089169722K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAYDJG2014-01-17
1894081010224007
1894081078154003
1894081152344422
1894081163044975
1894081184675637
1894081233137078
1894081273626909
1894081323486111
1894081334725507
1894081345409636
1894081432935253
1894081483842003
1894081586086590
1894081586796532
1894081621109158
1894081632536481
1894081640117475
1894081645772987
1894081689406705
1894081706201355
1894081763322951
1894081767320045
1894081809196785
1894081810367027
1894081885945471
1894081904051568
1894081928787111
1894081967391994
1894082031413759
1894082058301582

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG62017-06-14
PJD22019-07-29
QBK12019-11-15
DIC12018-10-31
DIS12016-10-14
LAF12016-03-18
JXM12016-01-05
LCM12015-09-04
DJR12015-07-24
DIO12015-06-29
LDJ12015-06-05
DKZ12015-02-06