Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum
FDA 510(k) K052056 · Thermo-Electron Corp.
510(k) numberK052056
Submission
- Device name
- Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum
- Applicant
- Thermo-Electron Corp.
Noble Park, AU - Received
- July 29, 2005
- Decision date
- September 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum cleared by the FDA?
Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum (K052056) received a 510(k) decision of Substantially Equivalent on September 23, 2005, 56 days after the submission was received.
What is the product code of K052056?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.