Microalbumin Multi-Calibrator Set
FDA 510(k) K042243 · Diagnostic Chemicals , Ltd.
510(k) numberK042243
Submission
- Device name
- Microalbumin Multi-Calibrator Set
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, Prince Edward, CA - Received
- August 19, 2004
- Decision date
- October 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Microalbumin Multi-Calibrator Set cleared by the FDA?
Microalbumin Multi-Calibrator Set (K042243) received a 510(k) decision of Substantially Equivalent on October 4, 2004, 46 days after the submission was received.
What is the product code of K042243?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.