Rdi HS CRP Calibrator Set
FDA 510(k) K021607 · Reference Diagnostics, Inc.
510(k) numberK021607
Submission
- Device name
- Rdi HS CRP Calibrator Set
- Applicant
- Reference Diagnostics, Inc.
Bedford, MA, US - Received
- May 16, 2002
- Decision date
- June 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Rdi HS CRP Calibrator Set cleared by the FDA?
Rdi HS CRP Calibrator Set (K021607) received a 510(k) decision of Substantially Equivalent on June 27, 2002, 42 days after the submission was received.
What is the product code of K021607?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.