510(k) K960075
K960075 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "CHROMAGAR CANDIDA". The FDA issued a decision of Substantially Equivalent on August 2, 1996. The device falls under product code JXC (Kit, Screening, Yeast), a Class I device regulated under 21 CFR 866.2660. Hardy Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1996
- Date Received
- January 11, 1996
- 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