510(k) K792420
K792420 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "SIM MEDIUM". The FDA issued a decision of Substantially Equivalent on December 31, 1979. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1979
- Date Received
- November 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Multiple Biochemical Test
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type