510(k) K860153

OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS by Oxoid U.S.A., Inc. — Product Code JTN

K860153 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
January 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type