Emit (R) II Phencyclidine Assay
FDA 510(k) K904765 · Syva Co.
510(k) numberK904765
Submission
- Device name
- Emit (R) II Phencyclidine Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- October 22, 1990
- Decision date
- November 28, 1990
- 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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| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
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| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit (R) II Phencyclidine Assay cleared by the FDA?
Emit (R) II Phencyclidine Assay (K904765) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 37 days after the submission was received.
What is the product code of K904765?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.