Psychemedics Ria Phencyclidine Assay
FDA 510(k) K011275 · Psychemedics Corp.
510(k) numberK011275
Submission
- Device name
- Psychemedics Ria Phencyclidine Assay
- Applicant
- Psychemedics Corp.
Culver City, CA, US - Received
- April 26, 2001
- Decision date
- February 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCL – Radioimmunoassay, Phencyclidine
- Device class
- Unclassified
Other 510(k)s with product code LCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | 04/18/2022SE |
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| K123799 | Psychemedics Microplate Eia for Oxycodone in HairDJG · Traditional | 02/08/2013SE |
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Questions and answers
When was Psychemedics Ria Phencyclidine Assay cleared by the FDA?
Psychemedics Ria Phencyclidine Assay (K011275) received a 510(k) decision of Substantially Equivalent on February 11, 2002, 291 days after the submission was received.
What is the product code of K011275?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.