TDX Phencyclidine II Assay
FDA 510(k) K900940 · Abbott Laboratories
510(k) numberK900940
Submission
- Device name
- TDX Phencyclidine II Assay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- February 28, 1990
- Decision date
- April 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 TDX Phencyclidine II Assay cleared by the FDA?
TDX Phencyclidine II Assay (K900940) received a 510(k) decision of Substantially Equivalent on April 25, 1990, 56 days after the submission was received.
What is the product code of K900940?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.