Abuscreen Radioimmunoassay-Cocaine Meta
FDA 510(k) K830480 · Hoffmann-La Roche, Inc.
510(k) numberK830480
Submission
- Device name
- Abuscreen Radioimmunoassay-Cocaine Meta
- Applicant
- Hoffmann-La Roche, Inc.
Walker, MI, US - Received
- February 15, 1983
- Decision date
- March 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLN – Radioimmunoassay, Cocaine Metabolite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010868 | Psychemedics Ria Cocaine AssayKLN · Traditional | Psychemedics Corp. | 11/06/2001SE |
| K913867 | Urine Cocaine Metabolite Direct Ria Kit (I-125)KLN · Traditional | Immunalysis Corporation | 09/19/1991SE |
| K913722 | Abuscreen(R) Radioimmun for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 09/10/1991SE |
| K912756 | Abuscreen Radioimmunoassay for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 07/26/1991SE |
| K910123 | Target Cocaine Metabolite-VKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | V-Tech, Inc. | 03/19/1991SE |
| K910044 | Milenia Cocaine MetaboliteKLN · Traditional | Diagnostic Products Corp. | 02/13/1991SE |
| K905730 | Abuscreen Ontrak for Cocaine (200NG/ML)KLN · Traditional | Roche Diagnostic Systems, Inc. | 01/15/1991SE |
| K904995 | Abuscreen Online TM for Cocaine MetaboliteKLN · Traditional | Roche Diagnostic Systems, Inc. | 11/28/1990SE |
| K880674 | Micromedic Crackpot Ria KitKLN · Traditional | Icn Micromedic Systems | 10/06/1988SE |
More from Icn Micromedic Systems
| 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 |
| 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 |
| K823579 | Cobas Reagent for Total ProteinCEK · Traditional | 01/07/1983SE |
Questions and answers
When was Abuscreen Radioimmunoassay-Cocaine Meta cleared by the FDA?
Abuscreen Radioimmunoassay-Cocaine Meta (K830480) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 37 days after the submission was received.
What is the product code of K830480?
The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.