Modification to Synchron Control
FDA 510(k) K013235 · Beckman Coulter, Inc.
510(k) numberK013235
Submission
- Device name
- Modification to Synchron Control
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- September 28, 2001
- Decision date
- October 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Modification to Synchron Control cleared by the FDA?
Modification to Synchron Control (K013235) received a 510(k) decision of Substantially Equivalent on October 16, 2001, 18 days after the submission was received.
What is the product code of K013235?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.