Emit Quinidine Assay
FDA 510(k) K862214 · Syva Co.
510(k) numberK862214
Submission
- Device name
- Emit Quinidine Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- June 10, 1986
- Decision date
- June 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBZ – Enzyme Immunoassay, Quinidine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | Seradyn, Inc. | 12/23/2005SE |
| K032332 | Roche Online TDM QuinidineLBZ · Traditional | Roche Diagnostics Corp. | 01/12/2004SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | Syva Co., Dade Behring, Inc. | 06/12/2001SE |
| K964116 | Quinidine Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)LBZ · Traditional | Bayer Corp. | 12/24/1996SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | Diagnostic Reagents, Inc. | 12/18/1996SE |
| K955568 | Innofluor Quinidine Assay SystemLBZ · Traditional | Oxis Intl., Inc. | 04/04/1996SE |
| K941440 | Cobas-Fp Quinidine Reagents and CalibratorsLBZ · Traditional | Roche Diagnostic Systems, Inc. | 07/06/1994SE |
| K922913 | Emit 2000 Quindine Assay Quididine CalibratorsLBZ · Traditional | Syva Co. | 08/24/1992SE |
| K904990 | Emit Convenience Pack, Quinidine Assay/CalibratorsLBZ · Traditional | Syva Co. | 02/04/1991SE |
| K900705 | Modified Accufluor Quinidine Reagent & CalibratorLBZ · Traditional | Innotron of Oregon, Inc. | 04/12/1990SE |
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| 510(k) | Device | Decision |
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| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| 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 Quinidine Assay cleared by the FDA?
Emit Quinidine Assay (K862214) received a 510(k) decision of Substantially Equivalent on June 27, 1986, 17 days after the submission was received.
What is the product code of K862214?
The FDA product code is LBZ – Enzyme Immunoassay, Quinidine, a Class II (moderate risk) device regulated under 21 CFR 862.3320.