510(k) K832653

CEFUROXIME 30MCG. SUSCEP DISK by General Diagnostics — Product Code JTN

K832653 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "CEFUROXIME 30MCG. SUSCEP DISK". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 8, 1983
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