Revised Labeling for TDX Phencyclidine
FDA 510(k) K874484 · Abbott Laboratories
510(k) numberK874484
Submission
- Device name
- Revised Labeling for TDX Phencyclidine
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- October 30, 1987
- Decision date
- November 23, 1987
- 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 |
| 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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Questions and answers
When was Revised Labeling for TDX Phencyclidine cleared by the FDA?
Revised Labeling for TDX Phencyclidine (K874484) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 24 days after the submission was received.
What is the product code of K874484?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.