510(k) K913426
K913426 is an FDA 510(k) premarket notification submitted by Jrga Diagnostics for the device "ALBICANS SURE". The FDA issued a decision of Substantially Equivalent on April 22, 1992. The device falls under product code JXC (Kit, Screening, Yeast), a Class I device regulated under 21 CFR 866.2660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1992
- Date Received
- August 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Yeast
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type