510(k) K093724
K093724 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION". The FDA issued a decision of Substantially Equivalent on Jul 29, 2010. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Taidoc Technology Corporation has 122 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2010
- Date Received
- Dec 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt