Emit -D.A.U. Cannabinoid Urine Assay
FDA 510(k) K800246 · Syva Co.
510(k) numberK800246
Submission
- Device name
- Emit -D.A.U. Cannabinoid Urine Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- February 5, 1980
- Decision date
- February 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Immunalysis Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit -D.A.U. Cannabinoid Urine Assay cleared by the FDA?
Emit -D.A.U. Cannabinoid Urine Assay (K800246) received a 510(k) decision of Substantially Equivalent on February 26, 1980, 21 days after the submission was received.
What is the product code of K800246?
The FDA product code is LAT – Radioimmunoassay, Cannabinoid(S), a Class II (moderate risk) device regulated under 21 CFR 862.3870.