Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D
FDA 510(k) K033809 · Dade Behring, Inc.
510(k) numberK033809
Submission
- Device name
- Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- December 8, 2003
- Decision date
- February 20, 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
Other 510(k)s with product code KLR
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|---|---|---|---|
| K090282 | QMS LidocaineKLR · Traditional | Thermo Fisher Scientific, Inc. | 05/29/2009SE |
| K032334 | Roche Online TDM LidocaineKLR · Traditional | Roche Diagnostics Corp. | 01/12/2004SE |
| 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 Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D cleared by the FDA?
Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D (K033809) received a 510(k) decision of Substantially Equivalent on February 20, 2004, 74 days after the submission was received.
What is the product code of K033809?
The FDA product code is KLR – Enzyme Immunoassay, Lidocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3555.