At Work Drug Test, Model 9145-25C; Model 9177-25C
FDA 510(k) K994093 · Phamatech
510(k) numberK994093
Submission
- Device name
- At Work Drug Test, Model 9145-25C; Model 9177-25C
- Applicant
- Phamatech
San Diego, CA, US - Received
- December 3, 1999
- Decision date
- December 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K011275 | Psychemedics Ria Phencyclidine AssayLCL · Traditional | Psychemedics Corp. | 02/11/2002SE |
| 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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| K043599 | Moments Menopause Check, Model 9113CGJ · Special | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | 02/07/2005SE |
| K043167 | Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XJXM · Special | 12/29/2004SE |
| K041578 | Quickscreen, Models 9177X and 9178XLCM · Special | 09/10/2004SE |
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Questions and answers
When was At Work Drug Test, Model 9145-25C; Model 9177-25C cleared by the FDA?
At Work Drug Test, Model 9145-25C; Model 9177-25C (K994093) received a 510(k) decision of Substantially Equivalent on December 16, 1999, 13 days after the submission was received.
What is the product code of K994093?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.