Emit ST Urine Phencyclidine Assay
FDA 510(k) K840061 · Syva Co.
510(k) numberK840061
Submission
- Device name
- Emit ST Urine Phencyclidine Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 9, 1984
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
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| 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 |
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Questions and answers
When was Emit ST Urine Phencyclidine Assay cleared by the FDA?
Emit ST Urine Phencyclidine Assay (K840061) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 70 days after the submission was received.
What is the product code of K840061?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.