Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071
FDA 510(k) K021887 · Lin-Zhi International, Inc.
510(k) numberK021887
Submission
- Device name
- Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071
- Applicant
- Lin-Zhi International, Inc.
San Jose, CA, US - Received
- June 7, 2002
- Decision date
- August 15, 2002
- 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 |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| 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 |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | 01/16/2026SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | 06/18/2025SE |
| K202007 | LZI Oxycodone III Enzyme ImmunoassayDJG · Traditional | 09/17/2020SE |
| K201938 | LZI Fentanyl II Enzyme ImmunoassayDJG · Traditional | 08/07/2020SE |
| K201223 | LZI Tramadol Enzyme ImmunoassayDJG · Traditional | 06/04/2020SE |
| K192299 | LZI Cotinine II Enzyme ImmunoassayMKU · Traditional | 11/21/2019SE |
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | 10/04/2019SE |
| K181159 | LZI Fentanyl Enzyme ImmunoassayDJG · Traditional | 12/03/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | 06/26/2017SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | 05/28/2015SE |
Questions and answers
When was Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071 cleared by the FDA?
Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071 (K021887) received a 510(k) decision of Substantially Equivalent on August 15, 2002, 69 days after the submission was received.
What is the product code of K021887?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.