Emit Hva Phencyclidine Assay
FDA 510(k) K882179 · Syva Co.
510(k) numberK882179
Submission
- Device name
- Emit Hva Phencyclidine Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- May 24, 1988
- Decision date
- July 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCL – Radioimmunoassay, Phencyclidine
- Device class
- Unclassified
Other 510(k)s with product code LCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011275 | Psychemedics Ria Phencyclidine AssayLCL · Traditional | Psychemedics Corp. | 02/11/2002SE |
| K994093 | At Work Drug Test, Model 9145-25C; Model 9177-25CLCL · Special | Phamatech | 12/16/1999SE |
| K913864 | PCP Direct Ria Kit (I-125)LCL · Traditional | Immunalysis Corporation | 10/11/1991SE |
| K890882 | Abuscreen FP for PhencyclidineLCL · Traditional | Roche Diagnostic Systems, Inc. | 03/15/1989SE |
| K880011 | Revised Labeling for Adx PhencyclidineLCL · Traditional | Abbott Laboratories | 02/11/1988SE |
| K874626 | Revised Labeling for Syva Phencyclidine AssaysLCL · Traditional | Syva Co. | 01/11/1988SE |
| K874484 | Revised Labeling for TDX PhencyclidineLCL · Traditional | Abbott Laboratories | 11/23/1987SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
| K800514 | Phencyclidine Direct Blood Ria KitLCL · Traditional | Immunalysis Corporation | 03/19/1980SE |
| K790655 | Abuscreen Ria for PhencyclidineLCL · Traditional | Hoffmann-La Roche, Inc. | 06/15/1979SE |
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| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
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| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| 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 Hva Phencyclidine Assay cleared by the FDA?
Emit Hva Phencyclidine Assay (K882179) received a 510(k) decision of Substantially Equivalent on July 12, 1988, 49 days after the submission was received.
What is the product code of K882179?
The FDA product code is LCL – Radioimmunoassay, Phencyclidine, a Unclassified device.