Emit 2000 Carbamazepine Assay, Model OSR4F229
FDA 510(k) K010814 · Syva Co., Dade Behring, Inc.
510(k) numberK010814
Submission
- Device name
- Emit 2000 Carbamazepine Assay, Model OSR4F229
- Applicant
- Syva Co., Dade Behring, Inc.
San Jose, CA, US - Received
- March 19, 2001
- Decision date
- April 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLT – Enzyme Immunoassay, Carbamazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
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|---|---|---|---|
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| K123518 | Abbott Carbamazepine AssayKLT · Traditional | Microgenics Corporation | 06/05/2013SE |
| K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsKLT · Traditional | Abbott Laboratories | 10/14/2011SE |
| K063131 | Carbamazepine, Valproic Acid, TDM Calibration Set B and Abtrol, Nortrol ControlsKLT · Traditional | Thermo Electron OY | 10/05/2007SE |
| K042808 | Advia Ims Carbamazepine MethodKLT · Traditional | Bayer Healthcare, LLC | 02/08/2005SE |
| K031902 | Online TDM CarbamazepineKLT · Traditional | Roche Diagnostics Corp. | 09/17/2003SE |
| K011648 | Randox CarbamazepineKLT · Traditional | Randox Laboratories, Ltd. | 01/15/2002SE |
| K000903 | Additional Assays for Bayer Advia Ims SystemKLT · Traditional | Bayer Corp. | 05/18/2000SE |
| K000007 | Immulite Carbamazepine, Immulite 2000 Carbamazepine, Catalog # LKCB1, LKCB5 & L2KCB2…KLT · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | Syva Co. | 01/27/2000SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | 06/18/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | 05/15/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
Questions and answers
When was Emit 2000 Carbamazepine Assay, Model OSR4F229 cleared by the FDA?
Emit 2000 Carbamazepine Assay, Model OSR4F229 (K010814) received a 510(k) decision of Substantially Equivalent on April 13, 2001, 25 days after the submission was received.
What is the product code of K010814?
The FDA product code is KLT – Enzyme Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.