Abuscreen Radioimmunoassay for Cannabi
FDA 510(k) K820391 · Hoffmann-La Roche, Inc.
510(k) numberK820391
Submission
- Device name
- Abuscreen Radioimmunoassay for Cannabi
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- February 10, 1982
- Decision date
- March 8, 1982
- 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 |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was Abuscreen Radioimmunoassay for Cannabi cleared by the FDA?
Abuscreen Radioimmunoassay for Cannabi (K820391) received a 510(k) decision of Substantially Equivalent on March 8, 1982, 26 days after the submission was received.
What is the product code of K820391?
The FDA product code is LAT – Radioimmunoassay, Cannabinoid(S), a Class II (moderate risk) device regulated under 21 CFR 862.3870.