Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with Electrolytes
FDA 510(k) K090734 · Medica Corp.
510(k) numberK090734
Submission
- Device name
- Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with Electrolytes
- Applicant
- Medica Corp.
Bedford, MA, US - Received
- March 19, 2009
- Decision date
- July 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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Questions and answers
When was Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with Electrolytes cleared by the FDA?
Easyra DLDL Reagent, Calibrator; Easyqc Chemistry No Electrolytes, with Electrolytes (K090734) received a 510(k) decision of Substantially Equivalent on July 17, 2009, 120 days after the submission was received.
What is the product code of K090734?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.