Psychemedics Ria Cannabinoid Assay
FDA 510(k) K011426 · Psychemedics Corp.
510(k) numberK011426
Submission
- Device name
- Psychemedics Ria Cannabinoid Assay
- Applicant
- Psychemedics Corp.
Culver City, CA, US - Received
- May 8, 2001
- Decision date
- May 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAT – Radioimmunoassay, Cannabinoid(S)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961620 | Abiscreen Online for Cannabinoids - Es 50/100LAT · Traditional | Roche Diagnostic Systems, Inc. | 06/13/1996SE |
| K936135 | Sudormed Sweat Patch Specimen Container for Collection of Marijuana in PerspirationLAT · Traditional | Sudormed, Inc. | 06/10/1996SE |
| K914507 | Double Antibody Cannabionoids/Quail Deter in UrineLAT · Traditional | Diagnostic Products Corp. | 12/18/1991SE |
| K913414 | Abuscreen(R) Online(Tm) for THC(50/100)(100TEST KTLAT · Traditional | Roche Diagnostic Systems, Inc. | 09/25/1991SE |
| K913865 | Urine THC Direct Ria Kit (I-125)LAT · Traditional | Immunalysis Corporation | 09/18/1991SE |
| K912574 | Abuscreen Online for THC (50 and 100)LAT · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1991SE |
| K904996 | Abuscreen Online TM for THCLAT · Traditional | Roche Diagnostic Systems, Inc. | 01/11/1991SE |
| K843534 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 10/30/1984SE |
| K833911 | Urine THC Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 01/24/1984SE |
| K821965 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 07/20/1982SE |
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| K111929 | Psychemedics Cannabinoids EiaLDJ · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Ria Cannabinoid Assay cleared by the FDA?
Psychemedics Ria Cannabinoid Assay (K011426) received a 510(k) decision of Substantially Equivalent on May 3, 2002, 360 days after the submission was received.
What is the product code of K011426?
The FDA product code is LAT – Radioimmunoassay, Cannabinoid(S), a Class II (moderate risk) device regulated under 21 CFR 862.3870.