Quinidine Enzyme Immunoassay
FDA 510(k) K964212 · Diagnostic Reagents, Inc.
510(k) numberK964212
Submission
- Device name
- Quinidine Enzyme Immunoassay
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- October 22, 1996
- Decision date
- December 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LBZ – Enzyme Immunoassay, Quinidine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| 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 |
| 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 |
| K892208 | Innofluor(Tm) Quinidine Reagent SetLBZ · Traditional | Innotron of Oregon, Inc. | 06/09/1989SE |
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| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
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| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
| K962463 | Procainamide Enzyme ImmunoassayLAR · Traditional | 08/14/1996SE |
Questions and answers
When was Quinidine Enzyme Immunoassay cleared by the FDA?
Quinidine Enzyme Immunoassay (K964212) received a 510(k) decision of Substantially Equivalent on December 18, 1996, 57 days after the submission was received.
What is the product code of K964212?
The FDA product code is LBZ – Enzyme Immunoassay, Quinidine, a Class II (moderate risk) device regulated under 21 CFR 862.3320.