Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298
FDA 510(k) K091742 · Beckman Coulter, Inc.
510(k) numberK091742
Submission
- Device name
- Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- June 16, 2009
- Decision date
- August 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFY – Enzymatic Method, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional | ACON Laboratories, Inc. | 12/22/2014SE |
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Questions and answers
When was Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298 cleared by the FDA?
Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298 (K091742) received a 510(k) decision of Substantially Equivalent on August 14, 2009, 59 days after the submission was received.
What is the product code of K091742?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.