Synchron Creatinine Triggered Test CX4,5,7,
FDA 510(k) K915077 · Beckman Instruments, Inc.
510(k) numberK915077
Submission
- Device name
- Synchron Creatinine Triggered Test CX4,5,7,
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- November 8, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGX – Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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Questions and answers
When was Synchron Creatinine Triggered Test CX4,5,7, cleared by the FDA?
Synchron Creatinine Triggered Test CX4,5,7, (K915077) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 40 days after the submission was received.
What is the product code of K915077?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.