Roche Online TDM Quinidine
FDA 510(k) K032332 · Roche Diagnostics Corp.
510(k) numberK032332
Submission
- Device name
- Roche Online TDM Quinidine
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- July 29, 2003
- Decision date
- January 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | Seradyn, Inc. | 12/23/2005SE |
| 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 |
| K892208 | Innofluor(Tm) Quinidine Reagent SetLBZ · Traditional | Innotron of Oregon, Inc. | 06/09/1989SE |
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Questions and answers
When was Roche Online TDM Quinidine cleared by the FDA?
Roche Online TDM Quinidine (K032332) received a 510(k) decision of Substantially Equivalent on January 12, 2004, 167 days after the submission was received.
What is the product code of K032332?
The FDA product code is LBZ – Enzyme Immunoassay, Quinidine, a Class II (moderate risk) device regulated under 21 CFR 862.3320.