Oxalate Urine Controls (Normal and Elevated)
FDA 510(k) K062521 · Thermo-Electron Corp.
510(k) numberK062521
Submission
- Device name
- Oxalate Urine Controls (Normal and Elevated)
- Applicant
- Thermo-Electron Corp.
Noble Park, AU - Received
- August 28, 2006
- Decision date
- March 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Oxalate Urine Controls (Normal and Elevated) cleared by the FDA?
Oxalate Urine Controls (Normal and Elevated) (K062521) received a 510(k) decision of Substantially Equivalent on March 16, 2007, 200 days after the submission was received.
What is the product code of K062521?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.