510(k) K820845

DULTURE MEDIA, SELECTIVE & NON-DIFFER by Blue Ridge Media Co. — Product Code JSJ

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

Source: FDA 510(k) database entry for K820845. Report a data issue: hello@regdatalab.com.