510(k) K850957

GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK by Warner-Lambert Co. — Product Code JTN

K850957 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
March 8, 1985
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