510(k) K820845
K820845 is an FDA 510(k) premarket notification submitted by Blue Ridge Media Co. for the device "DULTURE MEDIA, SELECTIVE & NON-DIFFER". The FDA issued a decision of Substantially Equivalent on Apr 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. Blue Ridge Media Co. has 10 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 16, 1982
- Date Received
- Mar 26, 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
- 510(k) Exempt