Validate Chem 6 Calibration Verification Test Set Model # 10006
FDA 510(k) K013119 · Maine Standards Co.
510(k) numberK013119
Submission
- Device name
- Validate Chem 6 Calibration Verification Test Set Model # 10006
- Applicant
- Maine Standards Co.
Windham, ME, US - Received
- September 18, 2001
- Decision date
- November 16, 2001
- 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 Validate Chem 6 Calibration Verification Test Set Model # 10006 cleared by the FDA?
Validate Chem 6 Calibration Verification Test Set Model # 10006 (K013119) received a 510(k) decision of Substantially Equivalent on November 16, 2001, 59 days after the submission was received.
What is the product code of K013119?
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.