Synchron Systems Carbamazepine Test System
FDA 510(k) K955644 · Beckman Instruments, Inc.
510(k) numberK955644
Submission
- Device name
- Synchron Systems Carbamazepine Test System
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- December 12, 1995
- Decision date
- February 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
| K151578 | Carbamazepine Gen 4KLT · Traditional | Roche Diagnostics Operations (Rdo) | 10/22/2015SE |
| K123518 | Abbott Carbamazepine AssayKLT · Traditional | Microgenics Corporation | 06/05/2013SE |
| K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsKLT · Traditional | Abbott Laboratories | 10/14/2011SE |
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| 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 |
| K010814 | Emit 2000 Carbamazepine Assay, Model OSR4F229KLT · Special | Syva Co., Dade Behring, Inc. | 04/13/2001SE |
| 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 |
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Questions and answers
When was Synchron Systems Carbamazepine Test System cleared by the FDA?
Synchron Systems Carbamazepine Test System (K955644) received a 510(k) decision of Substantially Equivalent on February 16, 1996, 66 days after the submission was received.
What is the product code of K955644?
The FDA product code is KLT – Enzyme Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.