On Call Multi-Drug Home Test Cup
FDA 510(k) K050878 · ACON Laboratories, Inc.
510(k) numberK050878
Submission
- Device name
- On Call Multi-Drug Home Test Cup
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- April 6, 2005
- Decision date
- June 8, 2005
- 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
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| 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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| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | 05/31/2024SE |
| K233373 | Flowflex® Plus COVID-19 Home TestQYT · Traditional | 04/19/2024SE |
| K230828 | Flowflex COVID-19 Antigen Home TestQYT · Traditional | 11/09/2023SE |
| K193318 | Distinct® Early Detection Pregnancy TestLCX · Traditional | 08/20/2020SE |
| K192175 | On Call Express II Blood Glucose Monitoring SystemNBW · Special | 10/17/2019SE |
Questions and answers
When was On Call Multi-Drug Home Test Cup cleared by the FDA?
On Call Multi-Drug Home Test Cup (K050878) received a 510(k) decision of Substantially Equivalent on June 8, 2005, 63 days after the submission was received.
What is the product code of K050878?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.