Modification to Synchron LX 20 Clinical Chemistry System
FDA 510(k) K011213 · Beckman Coulter, Inc.
510(k) numberK011213
Submission
- Device name
- Modification to Synchron LX 20 Clinical Chemistry System
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- April 20, 2001
- Decision date
- May 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
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Questions and answers
When was Modification to Synchron LX 20 Clinical Chemistry System cleared by the FDA?
Modification to Synchron LX 20 Clinical Chemistry System (K011213) received a 510(k) decision of Substantially Equivalent on May 16, 2001, 26 days after the submission was received.
What is the product code of K011213?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.