Quikpac II One Step Phencyclidine (PCP) Test
FDA 510(k) K981292 · Syntron Bioresearch, Inc.
510(k) numberK981292
Submission
- Device name
- Quikpac II One Step Phencyclidine (PCP) Test
- Applicant
- Syntron Bioresearch, Inc.
Simi Valley, CA, US - Received
- April 9, 1998
- Decision date
- May 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
Other 510(k)s with product code LCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | Psychemedics Corporation | 04/18/2022SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 04/20/2021SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | Immunalysis Corporation | 01/24/2019SE |
| K163220 | Atellica CH Phencyclidine (Pcp)LCM · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/06/2017SE |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM · Traditional | Immunalysis Corporation | 09/04/2015SE |
| K142044 | CR3 Keyless Split Sample Cup Phencyclidien - MethylenedioxymethamphetamineLCM · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 08/25/2014SE |
| K131181 | Omega Laboratories Hair Drug Screening Assay PhencyclidineLCM · Traditional | Omega Laboratories, Inc. | 06/25/2013SE |
| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | Biophor Diagnostics, Inc. | 04/25/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
More from Microgenics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K992990 | Quickpac II One Step Cocaine TestDIO · Traditional | 09/20/1999SE |
| K992748 | Drugcheck X Multidrug Screening DeviceDIO · Traditional | 09/02/1999SE |
| K992207 | Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test SystemDIO · Traditional | 07/22/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | 06/24/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | 11/18/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | 05/07/1998SE |
| K980349 | Quickpac II One Step Barbiturate TestDIS · Traditional | 03/03/1998SE |
| K974712 | Quikstrip One Step Barbiturate TestDIS · Traditional | 02/12/1998SE |
Questions and answers
When was Quikpac II One Step Phencyclidine (PCP) Test cleared by the FDA?
Quikpac II One Step Phencyclidine (PCP) Test (K981292) received a 510(k) decision of Substantially Equivalent on May 26, 1998, 47 days after the submission was received.
What is the product code of K981292?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.