510(k) K884208

LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) by Oxoid U.S.A., Inc. — Product Code KZI

K884208 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1988
Date Received
October 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
Review Panel
MI
Submission Type