Lidocaine Fluorescent Immunoassay
FDA 510(k) K822347 · American Diagnostic Corp.
510(k) numberK822347
Submission
- Device name
- Lidocaine Fluorescent Immunoassay
- Applicant
- American Diagnostic Corp.
Walker, MI, US - Received
- August 6, 1982
- Decision date
- August 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Lidocaine Fluorescent Immunoassay cleared by the FDA?
Lidocaine Fluorescent Immunoassay (K822347) received a 510(k) decision of Substantially Equivalent on August 25, 1982, 19 days after the submission was received.
What is the product code of K822347?
The FDA product code is KLR – Enzyme Immunoassay, Lidocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3555.