Crp-Advance Multi Calibrator Set, Model SE-250
FDA 510(k) K060140 · Diagnostic Chemicals , Ltd.
510(k) numberK060140
Submission
- Device name
- Crp-Advance Multi Calibrator Set, Model SE-250
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- January 19, 2006
- Decision date
- April 24, 2006
- 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 Crp-Advance Multi Calibrator Set, Model SE-250 cleared by the FDA?
Crp-Advance Multi Calibrator Set, Model SE-250 (K060140) received a 510(k) decision of Substantially Equivalent on April 24, 2006, 95 days after the submission was received.
What is the product code of K060140?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.