Milenia(Tm) Cannabinoids
FDA 510(k) K901568 · Diagnostic Products Corp.
510(k) numberK901568
Submission
- Device name
- Milenia(Tm) Cannabinoids
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- April 4, 1990
- Decision date
- May 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| 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 |
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|---|---|---|
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| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Milenia(Tm) Cannabinoids cleared by the FDA?
Milenia(Tm) Cannabinoids (K901568) received a 510(k) decision of Substantially Equivalent on May 17, 1990, 43 days after the submission was received.
What is the product code of K901568?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.