Synchron Systems Dat Low and High Urine Calibrators II
FDA 510(k) K983747 · Beckman Coulter, Inc.
510(k) numberK983747
Submission
- Device name
- Synchron Systems Dat Low and High Urine Calibrators II
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- October 23, 1998
- Decision date
- December 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Synchron Systems Dat Low and High Urine Calibrators II cleared by the FDA?
Synchron Systems Dat Low and High Urine Calibrators II (K983747) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 68 days after the submission was received.
What is the product code of K983747?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.