510(k) K820863
K820863 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "MEDIA FOR IN-VITRO DIAGNOSTIC USE". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1982
- Date Received
- March 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Non-Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type