Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
FDA 510(k) K151203 · Immunalysis Corporation
510(k) numberK151203
Submission
- Device name
- Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- May 5, 2015
- Decision date
- June 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | Co-Innovation Biotech Co., Ltd. | 01/17/2024SE |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…LDJ · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 01/10/2024SE |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
| K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorLDJ · Traditional | Biophor Diagnostics, Inc. | 10/18/2013SE |
More from Biophor Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | 09/11/2025SE |
| K232898 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 11/21/2023SE |
| K223781 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/28/2023SE |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | 12/22/2021SE |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | 12/22/2021SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 04/20/2021SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 07/28/2020SE |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/29/2019SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
Questions and answers
When was Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set cleared by the FDA?
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (K151203) received a 510(k) decision of Substantially Equivalent on June 5, 2015, 31 days after the submission was received.
What is the product code of K151203?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.