# Immunalysis Corporation

- Location (FDA's records): Pomona, CA
- FDA decisions: 50 (1978–2025): 50 510(k) clearances
- Product codes: DJG (11), LAT (7), PJD (4), LAF (3), DIO (3), LCM (3), LCL (2), DKZ (2), KLN (2), CEP (1), LDJ (1), DJR (1)
- 510(k) review time since 2016: median 380 days, against 101 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 29 (5 its own); citations of its devices by later devices: 12 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lin-Zhi International, Inc.: 9 (https://510kreport.com/company/lin-zhi-international)
- Microgenics Corp.: 6 (https://510kreport.com/company/microgenics)
- Diagnostic Reagents, Inc.: 3 (https://510kreport.com/company/diagnostic-reagents)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)
- Biophor Diagnostics, Inc.: 1 (https://510kreport.com/company/biophor-diagnostics)
- Saliva Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/saliva-diagnostic-systems)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)

## Firms that cite its devices most
- Ark Diagnostics, Inc.: 2 (https://510kreport.com/company/ark-diagnostics)
- Quidel Cardiovascular, Inc.: 2 (https://510kreport.com/company/quidel-cardiovascular)
- Lin-Zhi International, Inc.: 1 (https://510kreport.com/company/lin-zhi-international)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Lmmunalysis Corporation: 1 (https://510kreport.com/company/lmmunalysis)

## Its most-cited devices
- K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (2017), cited by 2
- K151395: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (2015), cited by 2
- K183048: Quantisal II Oral Fluid Collection Device (2019), cited by 2
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay (2015), cited by 1
- K203564: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (2021), cited by 1
- K181135: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (2019), cited by 1

## Recent decisions
- K252520: SEFRIA™ Hydrocodone Oral Fluid (Sep 11, 2025)
- K232898: Quantisal™ Oral Fluid Collection Device (Nov 21, 2023)
- K223781: Quantisal™ II Oral Fluid Collection Device (Jul 28, 2023)
- K203564: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (Dec 22, 2021)
- K203647: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (Dec 22, 2021)
- K203489: SEFRIA PCP Oral Fluid Enzyme Immunoassay (Apr 20, 2021)
- K200801: Quantisal Oral Fluid Collection Device (Jul 28, 2020)
- K190397: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (Nov 15, 2019)

Source page: https://510kreport.com/company/immunalysis