Medical Device Manufacturer · US , Mchenry , IL

Immunalysis Corporation - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1978
50
Total
50
Cleared
0
Denied
50 devices
26-50 of 50
Cleared Nov 18, 2005
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578 · DIO
Toxicology · 157d
Cleared Oct 21, 2005
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · DKZ
Toxicology · 129d
Cleared Oct 13, 2005
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · DJG
Toxicology · 115d
Cleared Oct 04, 2005
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · LAF
Toxicology · 112d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465 · DIO
Chemistry · 154d
Cleared Apr 06, 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · DOE
Toxicology · 257d
Cleared Oct 11, 1991
PCP DIRECT RIA KIT (I-125)
K913864 · LCL
Toxicology · 45d
Cleared Sep 25, 1991
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866 · DJP
Toxicology · 29d
Cleared Sep 19, 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · DJG
Toxicology · 23d
Cleared Sep 19, 1991
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867 · KLN
Toxicology · 23d
Cleared Sep 18, 1991
URINE THC DIRECT RIA KIT (I-125)
K913865 · LAT
Toxicology · 22d
Cleared Jun 16, 1987
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · KLN
Chemistry · 63d
Cleared Jun 15, 1987
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
K871698 · DJG
Chemistry · 48d
Cleared Oct 30, 1984
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K843534 · LAT
Toxicology · 53d
Cleared Jan 24, 1984
URINE THC CANNABINOIDS DIRECT RIA KIT
K833911 · LAT
Toxicology · 71d
Cleared Jul 20, 1982
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K821965 · LAT
Chemistry · 18d
Cleared May 05, 1982
THC-CANNABINOIDS DIRECT URINE RIA KIT
K820903 · LAT
Toxicology · 35d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · CGJ
Chemistry · 22d
Cleared Jul 23, 1981
DHEA-SULFATE DIRECT RIA KIT(125I)
K811906 · JKC
Chemistry · 22d
Cleared Jul 23, 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · JLS
Chemistry · 22d
Cleared May 08, 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · CEP
Chemistry · 23d
Cleared Mar 19, 1980
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · LCL
Toxicology · 14d
Cleared Oct 11, 1979
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT
K791649 · LAT
Toxicology · 48d
Cleared Dec 04, 1978
DIRECT ESTRIOL RIA KIT
K781546 · CGI
Chemistry · 82d
Cleared Oct 03, 1978
THC DIRECT RIA KIT
K781048 · LAT
Toxicology · 104d
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