Roche Online TDM Lidocaine
FDA 510(k) K032334 · Roche Diagnostics Corp.
510(k) numberK032334
Submission
- Device name
- Roche Online TDM Lidocaine
- 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
- KLR – Enzyme Immunoassay, Lidocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3555
- Specialty
- Clinical Toxicology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090282 | QMS LidocaineKLR · Traditional | Thermo Fisher Scientific, Inc. | 05/29/2009SE |
| K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…KLR · Traditional | Dade Behring, Inc. | 02/20/2004SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | Diagnostic Reagents, Inc. | 09/12/1997SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | Diagnostic Systems | 06/20/1988SE |
| K853010 | Cobas Reagent for Lidocaine & CalibratorsKLR · Traditional | Roche Diagnostic Systems, Inc. | 08/07/1985SE |
| K843184 | Stratus Lidocaine Fluorometric EnzymeKLR · Traditional | American Dade | 09/26/1984SE |
| K833381 | Valproic Acid Analytical Test PackKLR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/27/1983SE |
| K833379 | Lidocaine Analytical Test Pack AcaKLR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/27/1983SE |
| K833623 | Modif. of Emit Cad Disopyramide AssayKLR · Traditional | Syva Co. | 12/08/1983SE |
| K832799 | Modifica- of Emit Cad Lidocaine AssayKLR · Traditional | Syva Co. | 10/14/1983SE |
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Questions and answers
When was Roche Online TDM Lidocaine cleared by the FDA?
Roche Online TDM Lidocaine (K032334) 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 K032334?
The FDA product code is KLR – Enzyme Immunoassay, Lidocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3555.