Ez-Screen:Pcp
FDA 510(k) K943711 · Editek, Inc.
510(k) numberK943711
Submission
- Device name
- Ez-Screen:Pcp
- Applicant
- Editek, Inc.
Burlington, NC, US - Received
- August 1, 1994
- Decision date
- September 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K963692 | Verdict PCPLCM · Traditional | 12/10/1996SE |
| K963233 | Ez-Screen ProfileLCM · Traditional | 10/31/1996SE |
| K963529 | Verdict BarbituratesDIS · Traditional | 10/30/1996SE |
| K963516 | Verdict THCLDJ · Traditional | 10/30/1996SE |
| K943712 | Verdict OpiatesDJG · Traditional | 11/17/1994SE |
| K943710 | Verdict CocaineDIO · Traditional | 11/17/1994SE |
Questions and answers
When was Ez-Screen:Pcp cleared by the FDA?
Ez-Screen:Pcp (K943711) received a 510(k) decision of Substantially Equivalent on September 9, 1994, 39 days after the submission was received.
What is the product code of K943711?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.