XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack
FDA 510(k) K130915 · Jas Diagnostics, Inc.
510(k) numberK130915
Submission
- Device name
- XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack
- Applicant
- Jas Diagnostics, Inc.
Miami Lakes, FL, US - Received
- April 2, 2013
- Decision date
- May 15, 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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| K133519 | Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional | Carolina Liquid Chemistries Corp. | 05/16/2014SE |
| K131554 | RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast)…JJE · Traditional | Randox Laboratories, Ltd. | 01/09/2014SE |
| K130276 | Dimension Exl with LM SystemJJE · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/22/2013SE |
| K113253 | Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein Reagent,Ace…JJE · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 05/17/2012SE |
| 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 |
| K051087 | Dimension Vista Integrated SystemJJE · Traditional | Dade Behring, Inc. | 07/11/2005SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | 11/17/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | 05/23/2008SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
| K021671 | Jas HDL Cholesterol (Automated) ReagentLBS · Traditional | 07/19/2002SE |
| K020454 | Chemistry CalibratorJIT · Traditional | 04/08/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | 12/21/2001SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | 09/06/2001SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | 08/21/2001SE |
Questions and answers
When was XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack cleared by the FDA?
XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack (K130915) received a 510(k) decision of Substantially Equivalent on May 15, 2014, 408 days after the submission was received.
What is the product code of K130915?
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.