Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration
FDA 510(k) K936135 · Sudormed, Inc.
510(k) numberK936135
Submission
- Device name
- Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration
- Applicant
- Sudormed, Inc.
Santa Ana, CA, US - Received
- December 28, 1993
- Decision date
- June 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K011426 | Psychemedics Ria Cannabinoid AssayLAT · Traditional | Psychemedics Corp. | 05/03/2002SE |
| K961620 | Abiscreen Online for Cannabinoids - Es 50/100LAT · Traditional | Roche Diagnostic Systems, Inc. | 06/13/1996SE |
| 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 |
More from Immunalysis Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K936240 | Sudormed Sweat Patch Speciment Container (Phencyclidine)JKA · Traditional | 03/19/1996SE |
| K935588 | Sudormed Sweat Patch Specimen Container for Collection of Amphetamines in PerspirationJKA · Traditional | 07/14/1995SE |
| K935564 | Sudormed Sweat Patch Specimen Container for Collection of Opiates in PerspirationJKA · Traditional | 07/14/1995SE |
| K926253 | Sudormed Sweat Patch Specimen Container: CocaineJKA · Traditional | 07/14/1995SE |
| K902442 | Sudormed Sweat Patch Specimen ContainerJKA · Traditional | 10/04/1990SE |
Questions and answers
When was Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration cleared by the FDA?
Sudormed Sweat Patch Specimen Container for Collection of Marijuana in Perspiration (K936135) received a 510(k) decision of Substantially Equivalent on June 10, 1996, 895 days after the submission was received.
What is the product code of K936135?
The FDA product code is LAT – Radioimmunoassay, Cannabinoid(S), a Class II (moderate risk) device regulated under 21 CFR 862.3870.