Medical Device Manufacturer · US , Mchenry , IL

Immunalysis Corporation - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 1978

Recent clearances: SEFRIA™ Hydrocodone Oral Fluid, Quantisal™ Oral Fluid Collection Device, Quantisal™ II Oral Fluid Collection Device

50

Total

50

Cleared

0

Denied

FDA 510(k) Regulatory Record - Immunalysis Corporation Chemistry ✕

13 devices

1-12 of 13

Cleared Nov 21, 2023

Quantisal™ Oral Fluid Collection Device

Chemistry · 64d

Cleared Jul 28, 2023

Quantisal™ II Oral Fluid Collection Device

Chemistry · 224d

Cleared Jul 28, 2020

Quantisal Oral Fluid Collection Device

Chemistry · 123d

Cleared Jul 29, 2019

Quantisal II Oral Fluid Collection Device

Chemistry · 269d

Cleared Aug 04, 2005

IMMUNALYSIS COCAINE ELISA FOR HAIR

Chemistry · 154d

Cleared Jun 16, 1987

RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]

Chemistry · 63d

Cleared Jun 15, 1987

RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]

Chemistry · 48d

Cleared Jul 20, 1982

ORAL THC-CANNABINOIDS DIRECT RIA KIT

Chemistry · 18d

Cleared Jul 23, 1981

FOLLICLE STIMULATING HORMONE DIRECT RIA

Chemistry · 22d

Cleared Jul 23, 1981

DHEA-SULFATE DIRECT RIA KIT(125I)

Chemistry · 22d

Cleared Jul 23, 1981

PROGESTERONE DIRECT RIA KIT (125I)

Chemistry · 22d

Cleared May 08, 1981

LUTEINIZING HORMONE DIRECT RIA KIT 125/I

Chemistry · 23d