Synchron CX 7 Clinical Analyzer
FDA 510(k) K904219 · Beckman
510(k) numberK904219
Submission
- Device name
- Synchron CX 7 Clinical Analyzer
- Applicant
- Beckman
Brea, CA, US - Received
- September 12, 1990
- Decision date
- October 22, 1990
- 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
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…DHX · Special | 06/01/1999SE |
| K971534 | Synchron Syustems Dat Drug Free Urine ControlDIF · Traditional | 05/21/1997SE |
| K935362 | P-Amylase ControlJJX · Traditional | 01/27/1994SE |
| K904220 | Synchron CX4-CEJJE · Traditional | 10/15/1990SE |
| K893583 | Beckman Cholinesterase Reagent KitDIH · Traditional | 08/15/1989SE |
Questions and answers
When was Synchron CX 7 Clinical Analyzer cleared by the FDA?
Synchron CX 7 Clinical Analyzer (K904219) received a 510(k) decision of Substantially Equivalent on October 22, 1990, 40 days after the submission was received.
What is the product code of K904219?
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.