Online Dat Phencyclidine Plus
FDA 510(k) K043305 · Roche Diagnostics Corp.
510(k) numberK043305
Submission
- Device name
- Online Dat Phencyclidine Plus
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- November 30, 2004
- Decision date
- January 10, 2005
- 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
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| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
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Questions and answers
When was Online Dat Phencyclidine Plus cleared by the FDA?
Online Dat Phencyclidine Plus (K043305) received a 510(k) decision of Substantially Equivalent on January 10, 2005, 41 days after the submission was received.
What is the product code of K043305?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.