Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2
FDA 510(k) K981706 · Abbott Laboratories
510(k) numberK981706
Submission
- Device name
- Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- May 14, 1998
- Decision date
- July 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2 cleared by the FDA?
Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise Calibrator Levels 1 and 2 (K981706) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 56 days after the submission was received.
What is the product code of K981706?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.