Synchron CX Systems Prealbumin Calibrator
FDA 510(k) K994169 · Beckman Coulter, Inc.
510(k) numberK994169
Submission
- Device name
- Synchron CX Systems Prealbumin Calibrator
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- December 10, 1999
- Decision date
- February 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Synchron CX Systems Prealbumin Calibrator cleared by the FDA?
Synchron CX Systems Prealbumin Calibrator (K994169) received a 510(k) decision of Substantially Equivalent on February 3, 2000, 55 days after the submission was received.
What is the product code of K994169?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.