Abuscreen FP for Phencyclidine
FDA 510(k) K890882 · Roche Diagnostic Systems, Inc.
510(k) numberK890882
Submission
- Device name
- Abuscreen FP for Phencyclidine
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- February 21, 1989
- Decision date
- March 15, 1989
- 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 |
| 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 |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
| 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 |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Abuscreen FP for Phencyclidine cleared by the FDA?
Abuscreen FP for Phencyclidine (K890882) received a 510(k) decision of Substantially Equivalent on March 15, 1989, 22 days after the submission was received.
What is the product code of K890882?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.