Roche Cobas(R)-Fp Reagent for Total T4 Thyrox/Cali
FDA 510(k) K926441 · Roche Diagnostic Systems, Inc.
510(k) numberK926441
Submission
- Device name
- Roche Cobas(R)-Fp Reagent for Total T4 Thyrox/Cali
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- December 23, 1992
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 Roche Cobas(R)-Fp Reagent for Total T4 Thyrox/Cali cleared by the FDA?
Roche Cobas(R)-Fp Reagent for Total T4 Thyrox/Cali (K926441) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 154 days after the submission was received.
What is the product code of K926441?
The FDA product code is KLT – Enzyme Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.