Synchron CX(TM)4 Clinical Analyzer
FDA 510(k) K881498 · Beckman Instruments, Inc.
510(k) numberK881498
Submission
- Device name
- Synchron CX(TM)4 Clinical Analyzer
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- April 8, 1988
- Decision date
- June 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code JJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…JJE · Traditional | Horiba, Ltd. | 02/12/2019SE |
| K133519 | Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional | Carolina Liquid Chemistries Corp. | 05/16/2014SE |
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | Jas Diagnostics, Inc. | 05/15/2014SE |
| 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 |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Synchron CX(TM)4 Clinical Analyzer cleared by the FDA?
Synchron CX(TM)4 Clinical Analyzer (K881498) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 54 days after the submission was received.
What is the product code of K881498?
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.