Advance Emit Cad Lidocaine Assay
FDA 510(k) K823866 · Syva Co.
510(k) numberK823866
Submission
- Device name
- Advance Emit Cad Lidocaine Assay
- Applicant
- Syva Co.
Walker, MI, US - Received
- December 23, 1982
- Decision date
- January 12, 1983
- 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
Other 510(k)s with product code KLR
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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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| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Advance Emit Cad Lidocaine Assay cleared by the FDA?
Advance Emit Cad Lidocaine Assay (K823866) received a 510(k) decision of Substantially Equivalent on January 12, 1983, 20 days after the submission was received.
What is the product code of K823866?
The FDA product code is KLR – Enzyme Immunoassay, Lidocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3555.