Fora Control Solution, Taidoc Control Solution
FDA 510(k) K093724 · Taidoc Technology Corporation
510(k) numberK093724
Submission
- Device name
- Fora Control Solution, Taidoc Control Solution
- Applicant
- Taidoc Technology Corporation
New Taipei City, TW - Received
- December 3, 2009
- Decision date
- July 29, 2010
- 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 Fora Control Solution, Taidoc Control Solution cleared by the FDA?
Fora Control Solution, Taidoc Control Solution (K093724) received a 510(k) decision of Substantially Equivalent on July 29, 2010, 238 days after the submission was received.
What is the product code of K093724?
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.