Calibrating Material, Calibrating Standards
FDA 510(k) K033060 · Diamond Diagnostics, Inc.
510(k) numberK033060
Submission
- Device name
- Calibrating Material, Calibrating Standards
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- September 29, 2003
- Decision date
- March 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Calibrating Material, Calibrating Standards cleared by the FDA?
Calibrating Material, Calibrating Standards (K033060) received a 510(k) decision of Substantially Equivalent on March 4, 2004, 157 days after the submission was received.
What is the product code of K033060?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.