Chrysalis Intelligence · Sponsors · Immunalysis Corporation

Immunalysis Corporation

Pomona, CA, US · 7 510(k) clearances

Total clearances
7
2020-07-28 → 2025-09-11
Last 12 months
1
Product codes
4
Most recent
2025-09-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device Class II Clinical Chemistry 3 2023-11-21
DJG Enzyme Immunoassay, Opiates Class II Clinical Toxicology 2 2025-09-11
LAF Gas Chromatography, Methamphetamine Class II Clinical Toxicology 1 2021-12-22
LCM Enzyme Immunoassay, Phencyclidine Unclassified Unknown 1 2021-04-20
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2025-09-11 K252520 SEFRIA™ Hydrocodone Oral Fluid DJG Class II Clinical Toxicology
2023-11-21 K232898 Quantisal™ Oral Fluid Collection Device PJD Class II Clinical Chemistry
2023-07-28 K223781 Quantisal™ II Oral Fluid Collection Device PJD Class II Clinical Chemistry
2021-12-22 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay LAF Class II Clinical Toxicology
2021-12-22 K203564 SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay DJG Class II Clinical Toxicology
2021-04-20 K203489 SEFRIA PCP Oral Fluid Enzyme Immunoassay LCM Unclassified Unknown
2020-07-28 K200801 Quantisal Oral Fluid Collection Device PJD Class II Clinical Chemistry