510(k) K960366

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES by Accumed Intl., Inc. — Product Code LTT

K960366 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES". The FDA issued a decision of Substantially Equivalent on April 9, 1996. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Accumed Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1996
Date Received
January 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panels, Test, Susceptibility, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type