510(k) K864764
K864764 is an FDA 510(k) premarket notification submitted by Clinical Convenience Products, Inc. for the device "CULTURIA MACCONKEY-MUG/CLED SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 29, 1986. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Clinical Convenience Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1986
- Date Received
- December 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type