510(k) K891593

LISTERIA SELECTIVE ENRICHMENT MEDIUM by Oxoid U.S.A., Inc. — Product Code JSI

K891593 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "LISTERIA SELECTIVE ENRICHMENT MEDIUM". The FDA issued a decision of Substantially Equivalent on June 9, 1989. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1989
Date Received
March 20, 1989
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