Synchron Systems Salicylate Reagent and Calibrator
FDA 510(k) K014173 · Beckman Coulter, Inc.
510(k) numberK014173
Submission
- Device name
- Synchron Systems Salicylate Reagent and Calibrator
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- December 20, 2001
- Decision date
- February 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKJ – Colorimetry, Salicylate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3830
- Specialty
- Clinical Toxicology
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Questions and answers
When was Synchron Systems Salicylate Reagent and Calibrator cleared by the FDA?
Synchron Systems Salicylate Reagent and Calibrator (K014173) received a 510(k) decision of Substantially Equivalent on February 15, 2002, 57 days after the submission was received.
What is the product code of K014173?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.