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Immunalysis Corporation

50 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SEFRIA™ Hydrocodone Oral Fluid (K252520)Immunalysis Corporation2025-09-11
Quantisal™ Oral Fluid Collection Device (K232898)Immunalysis Corporation2023-11-21
Quantisal™ II Oral Fluid Collection Device (K223781)Immunalysis Corporation2023-07-28
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (K203564)Immunalysis Corporation2021-12-22
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (K203647)Immunalysis Corporation2021-12-22
SEFRIA PCP Oral Fluid Enzyme Immunoassay (K203489)Immunalysis Corporation2021-04-20
Quantisal Oral Fluid Collection Device (K200801)Immunalysis Corporation2020-07-28
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (K190397)Immunalysis Corporation2019-11-15
Quantisal II Oral Fluid Collection Device (K183048)Immunalysis Corporation2019-07-29
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (K181135)Immunalysis Corporation2019-01-24
Immunalysis Ethyl Alcohol Enzyme Assay (K181553)Immunalysis Corporation2018-10-31
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (K161216)Immunalysis Corporation2017-06-14
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K161714)Immunalysis Corporation2016-10-14
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K153693)Immunalysis Corporation2016-03-18
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K151771)Immunalysis Corporation2016-01-05
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176)Immunalysis Corporation2015-09-04
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395)Immunalysis Corporation2015-07-24
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925)Immunalysis Corporation2015-06-29
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203)Immunalysis Corporation2015-06-05
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (K143502)Immunalysis Corporation2015-05-20
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (K150275)Immunalysis Corporation2015-03-09
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY (K141803)Immunalysis Corporation2015-02-12
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (K143500)Immunalysis Corporation2015-02-06
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS (K141406)Immunalysis Corporation2014-07-01
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY (K131168)Immunalysis Corporation2014-01-17
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS (K051578)Immunalysis Corporation2005-11-18
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS (K051579)Immunalysis Corporation2005-10-21
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS (K051626)Immunalysis Corporation2005-10-13
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS (K051577)Immunalysis Corporation2005-10-04
IMMUNALYSIS COCAINE ELISA FOR HAIR (K050465)Immunalysis Corporation2005-08-04
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K933572)Immunalysis Corporation1994-04-06
PCP DIRECT RIA KIT (I-125) (K913864)Immunalysis Corporation1991-10-11
URINE AMPHETAMINE DIRECT RIA KIT (I-125) (K913866)Immunalysis Corporation1991-09-25
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867)Immunalysis Corporation1991-09-19
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K913863)Immunalysis Corporation1991-09-19
URINE THC DIRECT RIA KIT (I-125) (K913865)Immunalysis Corporation1991-09-18
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (K871549)Immunalysis Corporation1987-06-16
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] (K871698)Immunalysis Corporation1987-06-15
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K843534)Immunalysis Corporation1984-10-30
URINE THC CANNABINOIDS DIRECT RIA KIT (K833911)Immunalysis Corporation1984-01-24
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K821965)Immunalysis Corporation1982-07-20
THC-CANNABINOIDS DIRECT URINE RIA KIT (K820903)Immunalysis Corporation1982-05-05
DHEA-SULFATE DIRECT RIA KIT(125I) (K811906)Immunalysis Corporation1981-07-23
PROGESTERONE DIRECT RIA KIT (125I) (K811907)Immunalysis Corporation1981-07-23
FOLLICLE STIMULATING HORMONE DIRECT RIA (K811905)Immunalysis Corporation1981-07-23
LUTEINIZING HORMONE DIRECT RIA KIT 125/I (K811024)Immunalysis Corporation1981-05-08
PHENCYCLIDINE DIRECT BLOOD RIA KIT (K800514)Immunalysis Corporation1980-03-19
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT (K791649)Immunalysis Corporation1979-10-11
DIRECT ESTRIOL RIA KIT (K781546)Immunalysis Corporation1978-12-04
THC DIRECT RIA KIT (K781048)Immunalysis Corporation1978-10-03

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Every clearance here is in the API, with alerts when new ones post.