510(k) K821229

CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK by General Diagnostics — Product Code JTN

K821229 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK". The FDA issued a decision of Substantially Equivalent on June 22, 1982. 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
June 22, 1982
Date Received
April 27, 1982
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