CX Phencyclidine Reagent for Synschron CX System
FDA 510(k) K944605 · Beckman-Diagnostic Systems Group
510(k) numberK944605
Submission
- Device name
- CX Phencyclidine Reagent for Synschron CX System
- Applicant
- Beckman-Diagnostic Systems Group
Brea, CA, US - Received
- September 19, 1994
- Decision date
- December 7, 1994
- 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 |
|---|---|---|
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | 12/12/1994SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | 12/07/1994SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | 11/30/1994SE |
| K942676 | Synchron CX3 DeltaJJF · Traditional | 11/02/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | 07/06/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | 04/26/1994SE |
| K936184 | Vigil PRX Chemistry ControlJJY · Traditional | 04/15/1994SE |
| K934271 | Beckman Synchron Lactate ReagentKHP · Traditional | 11/09/1993SE |
| K934046 | Beckman Cholesterol ReagentCHH · Traditional | 10/28/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | 10/27/1993SE |
Questions and answers
When was CX Phencyclidine Reagent for Synschron CX System cleared by the FDA?
CX Phencyclidine Reagent for Synschron CX System (K944605) received a 510(k) decision of Substantially Equivalent on December 7, 1994, 79 days after the submission was received.
What is the product code of K944605?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.