Synchron Systems Direct LDL Chloesterol Reagent and Calibrator
FDA 510(k) K014103 · Beckman Coulter, Inc.
510(k) numberK014103
Submission
- Device name
- Synchron Systems Direct LDL Chloesterol Reagent and Calibrator
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- December 13, 2001
- Decision date
- January 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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Questions and answers
When was Synchron Systems Direct LDL Chloesterol Reagent and Calibrator cleared by the FDA?
Synchron Systems Direct LDL Chloesterol Reagent and Calibrator (K014103) received a 510(k) decision of Substantially Equivalent on January 28, 2002, 46 days after the submission was received.
What is the product code of K014103?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.