Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
FDA 510(k) K152176 · Immunalysis Corporation
510(k) numberK152176
Submission
- Device name
- Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- Applicant
- Immunalysis Corporation
Pomona, CA, US - Received
- August 4, 2015
- Decision date
- September 4, 2015
- 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 |
| 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 |
| K093989 | Oral Fluid PhencyclidineLCM · Traditional | Roche Diagnostics | 01/25/2011SE |
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| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayDJG · Traditional | 12/22/2021SE |
| K203489 | SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 04/20/2021SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | 07/28/2020SE |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK · Traditional | 11/15/2019SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | 07/29/2019SE |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM · Traditional | 01/24/2019SE |
Questions and answers
When was Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators cleared by the FDA?
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176) received a 510(k) decision of Substantially Equivalent on September 4, 2015, 31 days after the submission was received.
What is the product code of K152176?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.