Micro-Strip for Phencyclidine Metabolites
FDA 510(k) K991505 · Microdiagnostics, Inc.
510(k) numberK991505
Submission
- Device name
- Micro-Strip for Phencyclidine Metabolites
- Applicant
- Microdiagnostics, Inc.
Laguna Niguel, CA, US - Received
- April 29, 1999
- Decision date
- August 5, 1999
- 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 |
|---|---|---|
| K011952 | Drugs of Abuse Multi-Test StripDKZ · Traditional | 10/25/2001SE |
| K991516 | Micro-Strip for Marijuana MetabolitesLDJ · Traditional | 08/05/1999SE |
| K981388 | Micro-Strip for Cocaine MetabolitesDIO · Traditional | 05/29/1998SE |
| K974611 | Micro-Strip for Amphetamine MetabolitesDKZ · Traditional | 03/20/1998SE |
| K973761 | Micro-Strip for Opiate MetabolitesDJG · Traditional | 12/24/1997SE |
| K932304 | Micro Eia for Amphetamine MetabolitesDKZ · Traditional | 12/07/1993SE |
| K923468 | Micro Eia for Opiate MetabolitesDJG · Traditional | 09/15/1992SE |
| K914533 | Micro Eia for Cocaine MetabolitesDIO · Traditional | 12/10/1991SE |
| K914490 | Micro Eia for Marijuana MetabolitesLDJ · Traditional | 11/29/1991SE |
Questions and answers
When was Micro-Strip for Phencyclidine Metabolites cleared by the FDA?
Micro-Strip for Phencyclidine Metabolites (K991505) received a 510(k) decision of Substantially Equivalent on August 5, 1999, 98 days after the submission was received.
What is the product code of K991505?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.