Abuscreen Radioimmunoassay-Phencyclidine
FDA 510(k) K830481 · Hoffmann-La Roche, Inc.
510(k) numberK830481
Submission
- Device name
- Abuscreen Radioimmunoassay-Phencyclidine
- 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
- LCL – Radioimmunoassay, Phencyclidine
- Device class
- Unclassified
Other 510(k)s with product code LCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011275 | Psychemedics Ria Phencyclidine AssayLCL · Traditional | Psychemedics Corp. | 02/11/2002SE |
| K994093 | At Work Drug Test, Model 9145-25C; Model 9177-25CLCL · Special | Phamatech | 12/16/1999SE |
| K913864 | PCP Direct Ria Kit (I-125)LCL · Traditional | Immunalysis Corporation | 10/11/1991SE |
| K890882 | Abuscreen FP for PhencyclidineLCL · Traditional | Roche Diagnostic Systems, Inc. | 03/15/1989SE |
| K882179 | Emit Hva Phencyclidine AssayLCL · Traditional | Syva Co. | 07/12/1988SE |
| K880011 | Revised Labeling for Adx PhencyclidineLCL · Traditional | Abbott Laboratories | 02/11/1988SE |
| K874626 | Revised Labeling for Syva Phencyclidine AssaysLCL · Traditional | Syva Co. | 01/11/1988SE |
| K874484 | Revised Labeling for TDX PhencyclidineLCL · Traditional | Abbott Laboratories | 11/23/1987SE |
| K800514 | Phencyclidine Direct Blood Ria KitLCL · Traditional | Immunalysis Corporation | 03/19/1980SE |
| K790655 | Abuscreen Ria for PhencyclidineLCL · Traditional | Hoffmann-La Roche, Inc. | 06/15/1979SE |
More from Hoffmann-La Roche, Inc.
| 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 |
| 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 |
| K823579 | Cobas Reagent for Total ProteinCEK · Traditional | 01/07/1983SE |
Questions and answers
When was Abuscreen Radioimmunoassay-Phencyclidine cleared by the FDA?
Abuscreen Radioimmunoassay-Phencyclidine (K830481) 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 K830481?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.