Synchron CX3 Delta
FDA 510(k) K942676 · Beckman-Diagnostic Systems Group
510(k) numberK942676
Submission
- Device name
- Synchron CX3 Delta
- Applicant
- Beckman-Diagnostic Systems Group
Brea, CA, US - Received
- June 6, 1994
- Decision date
- November 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
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More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | 12/12/1994SE |
| K944605 | CX Phencyclidine Reagent for Synschron CX SystemLCM · Traditional | 12/07/1994SE |
| K944604 | CX Amphetamines Reagent for Synchron CX SystemsDKZ · Traditional | 12/07/1994SE |
| K944606 | CX Opiate Reagent for Synchron CX SystemsDJG · Traditional | 11/30/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | 07/06/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | 04/26/1994SE |
| K936184 | Vigil PRX Chemistry ControlJJY · Traditional | 04/15/1994SE |
| K934271 | Beckman Synchron Lactate ReagentKHP · Traditional | 11/09/1993SE |
| K934046 | Beckman Cholesterol ReagentCHH · Traditional | 10/28/1993SE |
| K934467 | Beckman CX Ammonia/Alcohol ControlDKC · Traditional | 10/27/1993SE |
Questions and answers
When was Synchron CX3 Delta cleared by the FDA?
Synchron CX3 Delta (K942676) received a 510(k) decision of Substantially Equivalent on November 2, 1994, 149 days after the submission was received.
What is the product code of K942676?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.