Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3
FDA 510(k) K012431 · Bionostics, Inc.
510(k) numberK012431
Submission
- Device name
- Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- July 31, 2001
- Decision date
- August 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3 cleared by the FDA?
Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control, Levels 1,2,3 (K012431) received a 510(k) decision of Substantially Equivalent on August 28, 2001, 28 days after the submission was received.
What is the product code of K012431?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.