Data / Medical devices / United States / Alere San Diego, Inc.
Alere San Diego, Inc.: FDA-registered device maker in Pomona, CA, United States, 19 510(k) clearances
Alere San Diego, Inc. is registered with the FDA (registration 2020952) in Pomona, CA, United States. It lists 29 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 28, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2020952
- Address
- 829 Towne Center Dr, Pomona, CA, United States, 91767
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- June 30, 1998
- Registered through
- 2026
- Brand names listed
- 20X SSC, 500g, 6-Acetylmorphine Urine 10 Calibrator, 6-Acetylmorphine Urine Calibrator - 10 ng/mL, 6-Acetylmorphine Urine Control Set, 6-Acetylmorphine Urine Control Set 10, 2 x 5 mL, 6-Acetylmorphine Urine HEIA Kit 25, 6-Acetylmorphine Urine, 100 mL Kit, 6-Acetylmorphine Urine, 25 mL Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2023 | K223781 | Quantisal™ II Oral Fluid Collection Device | PJD | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| May 9, 2022 | K203527 | Immunalysis Tapentadol Urine HEIA | DJG | Substantially Equivalent | Lmmunalysis Corporation | accessdata.fda.gov |
| April 20, 2021 | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| November 15, 2019 | K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | QBK | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| October 31, 2018 | K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | DIC | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| June 14, 2017 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| October 14, 2016 | K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | DIS | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| March 18, 2016 | K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | LAF | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| January 5, 2016 | K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | JXM | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| September 4, 2015 | K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | LCM | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| July 24, 2015 | K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | DJR | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| June 29, 2015 | K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | DIO | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| June 5, 2015 | K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set | LDJ | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| May 20, 2015 | K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| March 9, 2015 | K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| February 12, 2015 | K141803 | IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| February 6, 2015 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set | DKZ | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| July 1, 2014 | K141406 | IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
| January 17, 2014 | K131168 | IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | Immunalysis Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 28, 2017 | 80096 | Class III | Terminated | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. Thi | The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized. | accessdata.fda.gov |
Compare with other makers
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- All makers of Enzyme Immunoassay, Amphetamine
- All makers of Alcohol Control Materials
Updated July 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.