Lidocaine Eia Assay
FDA 510(k) K973102 · Diagnostic Reagents, Inc.
510(k) numberK973102
Submission
- Device name
- Lidocaine Eia Assay
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- August 19, 1997
- Decision date
- September 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 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 |
| K032334 | Roche Online TDM LidocaineKLR · Traditional | Roche Diagnostics Corp. | 01/12/2004SE |
| 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 |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
| K962463 | Procainamide Enzyme ImmunoassayLAR · Traditional | 08/14/1996SE |
Questions and answers
When was Lidocaine Eia Assay cleared by the FDA?
Lidocaine Eia Assay (K973102) received a 510(k) decision of Substantially Equivalent on September 12, 1997, 24 days after the submission was received.
What is the product code of K973102?
The FDA product code is KLR – Enzyme Immunoassay, Lidocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3555.