510(k) K960996
K960996 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "M. CAT BUTYRATE DISK". The FDA issued a decision of Substantially Equivalent on Apr 18, 1996. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Hardy Diagnostics has 109 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 18, 1996
- Date Received
- Mar 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Discs, Strips And Reagents, Microorganism Differentiation
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt