Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270
FDA 510(k) K073055 · Dade Behring, Inc.
510(k) numberK073055
Submission
- Device name
- Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 30, 2007
- Decision date
- January 3, 2008
- 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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Questions and answers
When was Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270 cleared by the FDA?
Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270 (K073055) received a 510(k) decision of Substantially Equivalent on January 3, 2008, 65 days after the submission was received.
What is the product code of K073055?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.