Iron Calibrator & Calibration Verification Set
FDA 510(k) K955796 · Data Medical Associates, Inc.
510(k) numberK955796
Submission
- Device name
- Iron Calibrator & Calibration Verification Set
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- December 22, 1995
- Decision date
- February 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Iron Calibrator & Calibration Verification Set cleared by the FDA?
Iron Calibrator & Calibration Verification Set (K955796) received a 510(k) decision of Substantially Equivalent on February 29, 1996, 69 days after the submission was received.
What is the product code of K955796?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.