Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

50 results for "Immunalysis Corporation"
25–48 of 50
Search insights Median review: 71d Cleared: 100% Top manufacturer: Immunalysis Corporation Lead specialty: Toxicology
Cleared Jan 17, 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · DJG
Immunalysis Corporation
Toxicology · 268d
Cleared Nov 18, 2005
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578 · DIO
Immunalysis Corporation
Toxicology · 157d
Cleared Oct 21, 2005
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · DKZ
Immunalysis Corporation
Toxicology · 129d
Cleared Oct 13, 2005
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · DJG
Immunalysis Corporation
Toxicology · 115d
Cleared Oct 04, 2005
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · LAF
Immunalysis Corporation
Toxicology · 112d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465 · DIO
Immunalysis Corporation
Chemistry · 154d
Cleared Apr 06, 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · DOE
Immunalysis Corporation
Toxicology · 257d
Cleared Oct 11, 1991
PCP DIRECT RIA KIT (I-125)
K913864 · LCL
Immunalysis Corporation
Toxicology · 45d
Cleared Sep 25, 1991
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866 · DJP
Immunalysis Corporation
Toxicology · 29d
Cleared Sep 19, 1991
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867 · KLN
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 19, 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · DJG
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 18, 1991
URINE THC DIRECT RIA KIT (I-125)
K913865 · LAT
Immunalysis Corporation
Toxicology · 22d
Cleared Jun 16, 1987
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · KLN
Immunalysis Corporation
Chemistry · 63d
Cleared Jun 15, 1987
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
K871698 · DJG
Immunalysis Corporation
Chemistry · 48d
Cleared Oct 30, 1984
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K843534 · LAT
Immunalysis Corporation
Toxicology · 53d
Cleared Jan 24, 1984
URINE THC CANNABINOIDS DIRECT RIA KIT
K833911 · LAT
Immunalysis Corporation
Toxicology · 71d
Cleared Jul 20, 1982
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K821965 · LAT
Immunalysis Corporation
Chemistry · 18d
Cleared May 05, 1982
THC-CANNABINOIDS DIRECT URINE RIA KIT
K820903 · LAT
Immunalysis Corporation
Toxicology · 35d
Cleared Jul 23, 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · JLS
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
DHEA-SULFATE DIRECT RIA KIT(125I)
K811906 · JKC
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · CGJ
Immunalysis Corporation
Chemistry · 22d
Cleared May 08, 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · CEP
Immunalysis Corporation
Chemistry · 23d
Cleared Mar 19, 1980
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · LCL
Immunalysis Corporation
Toxicology · 14d
Cleared Oct 11, 1979
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT
K791649 · LAT
Immunalysis Corporation
Toxicology · 48d