Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car
FDA 510(k) K133519 · Carolina Liquid Chemistries Corp.
510(k) numberK133519
Submission
- Device name
- Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car
- Applicant
- Carolina Liquid Chemistries Corp.
Winston-Salem, NC, US - Received
- November 15, 2013
- Decision date
- May 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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| K131554 | RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast)…JJE · Traditional | Randox Laboratories, Ltd. | 01/09/2014SE |
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| K112999 | Dimension Clinical Chemistry SystemJJE · Special | Siemens Healthcare Diagnostics | 11/22/2011SE |
| K110035 | IndikoJJE · Traditional | Thermofisher Scientific OY | 06/28/2011SE |
| K073370 | TC Matrix Clinical Chemistry AnalyzerJJE · Traditional | Teco Diagnostics | 05/08/2008SE |
| K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemJJE · Special | Ortho-Clinical Diagnostics, Inc. | 11/13/2006SE |
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More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | 01/27/2022SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | 08/15/2017SE |
| K132711 | Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional | 05/08/2014SE |
| K972073 | Total Bilirubin ReagentCIG · Traditional | 06/24/1997SE |
| K971907 | Calcium ReagentCIC · Traditional | 06/24/1997SE |
| K971324 | Triglycerides, TG, or TrigCDT · Traditional | 06/20/1997SE |
| K971967 | BunCDQ · Traditional | 06/17/1997SE |
| K971908 | Crea or CreatinineCGX · Traditional | 06/17/1997SE |
| K971467 | Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional | 06/16/1997SE |
| K971396 | CK ReagentCGS · Traditional | 05/29/1997SE |
Questions and answers
When was Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car cleared by the FDA?
Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car (K133519) received a 510(k) decision of Substantially Equivalent on May 16, 2014, 182 days after the submission was received.
What is the product code of K133519?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.