510(k) K791546
K791546 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "COLUMBIA CNA BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code JSR (Kit, Identification, Dermatophyte), a Class I device regulated under 21 CFR 866.2660. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1979
- Date Received
- August 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Dermatophyte
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type