One Step Urine Drug of Abuse Cannabinoid Test (THC)
FDA 510(k) K951853 · Tcpi, Inc.
510(k) numberK951853
Submission
- Device name
- One Step Urine Drug of Abuse Cannabinoid Test (THC)
- Applicant
- Tcpi, Inc.
Pompano Beach, FL, US - Received
- April 21, 1995
- Decision date
- August 20, 1996
- 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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More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine TestJXM · Traditional | 04/29/1998SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | 07/26/1996SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | 07/22/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | 08/17/1995SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
Questions and answers
When was One Step Urine Drug of Abuse Cannabinoid Test (THC) cleared by the FDA?
One Step Urine Drug of Abuse Cannabinoid Test (THC) (K951853) received a 510(k) decision of Substantially Equivalent on August 20, 1996, 487 days after the submission was received.
What is the product code of K951853?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.